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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT
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| Model Number 241.901 |
| Device Problem
Device-Device Incompatibility (2919)
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| Patient Problems
Failure of Implant (1924); No Code Available (3191)
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| Event Date 01/01/2019 |
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Event Type
Injury
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Manufacturer Narrative
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It is unknown if the complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported on (b)(6) 2019, the patient underwent a proximal humerus fracture revision because one of the locking screws had backed out of the proximal humerus plate.It was noted the locking hole of the plate may have not locked.The patient was revised to a total shoulder.There was no surgical delay.Procedure was successfully completed.Patient outcome was unknown.Concomitant medical products reported: locking screws (part/lot unknown, quantity unknown) this report is for a proximal humerus plate.This is report 1 of 2 for (b)(4).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Updated event description: it was reported that on (b)(6) 2019, the patient underwent a right proximal humerus hardware removal and reverse total shoulder arthroplasty after a hardware failure.An unknown synthes screw was also removed due to loosening.On (b)(6) 2019, the patient underwent a right proximal humerus open reduction internal fixation and open biceps tenodesis and was implanted with a synthes proximal humerus 3-hole periarticular plant after sustaining a fracture and right shoulder pain of her right proximal humerus from a fall.Postoperatively, the patient had worsening anemia and received rbc transfusion before discharge.The patient has also reported mild discomfort prior to the removal surgery.On (b)(6) 2019, an x-ray was taken following first surgery which indicates a loose screw.On (b)(6) 2019, additional information from the sales consultant was received stating that the surgeon claims that the locking screw didn't lock proximally in the plate.It was noted the locking hole of the plate may have not locked.This complaint involves two (2) devices only.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Corrected data: awareness date reported on follow up 3 report as (b)(6) 2019 but should have been (b)(6) 2020.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Updated event description: it was reported that on (b)(6) 2019, the patient underwent a right proximal humerus hardware removal and reverse total shoulder arthroplasty after a hardware failure.An unknown synthes screw was also removed due to loosening.On (b)(6) 2019, the patient underwent a right proximal humerus open reduction internal fixation and open biceps tenodesis and was implanted with a synthes proximal humerus 3-hole periarticular plant after sustaining a fracture and right shoulder pain of her right proximal humerus from a fall.Postoperatively, the patient had worsening anemia and received rbc transfusion before discharge.The patient has also reported mild discomfort prior to the removal surgery.On (b)(6) 2019, an x-ray was taken following first surgery which indicates a loose screw.This complaint involves two (2) devices only.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.B3: event date is unknown in the year 2020.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: customer retaining the products.H6: patient code 3191 used to capture: the reported event required medical/surgical intervention.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: h3, h6: part: 241.901, lot: 5l84390, manufacturing site: raron, release to warehouse date: 26.August 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the titanium plate was received on july 21, 2020.The plate is identified as article number: 241.901 (3.5mm lcp® proximal humerus plate-standard 3h shaft/90mm) with the lot number: 5l84390.Upon visual inspection, the device had some cosmetic scratches that are consistent with implantation/explantation and would not have contributed to the reported complaint condition.Device failure/defect identified? yes.Dimensional inspection: according to the product quality plan (pqp) for the product in scope the following features are listed as critical to quality (ctq).Ctq relevant for reported complaint condition: hole positions and angles.Ensure hole position and angles to match with bone geometry.It is relevant for the reported complaint condition and will be evaluated.Thread specification and position: ensure thread specification of plate threading properly with its appropriate screws.It is relevant for the reported complaint condition and will be evaluated.Guide block mating holes diameter: ensure hole diameter perfectly mates with the guiding block.It is relevant for the reported complaint condition and will be evaluated.Plate thickness: ensure plate thickness to avoid breakages while handling.The feature has no influence on the complaint.Check ball height: ensure check ball height to avoid protrusion of screw head.The ctq feature is relevant for the reported complaint condition and will be evaluated.Locking thread zero gage line: ensure locking thread zero gage line to determine starting point of thread form.It is relevant for the reported complaint condition and will be evaluated.Etching: ensuring correct product identification and proper function of device.Incorrect marking of the device could lead to patient harms related to incorrect use of the device.The feature ¿etching¿ has no influence on the complaint.Raw material: ensuring product biocompatibility, functionality, mechanical strength, and ability to be cleaned / reprocessed.Incorrect material could lead to patient harms related to the mechanical performance of the device as well as adverse tissue reaction and infection.Visual inspection is sufficient.It is not relevant for the reported complaint condition and will be not evaluated.The feature has no influence on the complaint suture holes edge chamfer / round.Ensure edge chamfer to avoid complication during procedures.It is not relevant for the reported complaint condition and will be not evaluated.The feature has no influence on the complaint.Sterility of sterile offered products: maintain sterility of products to ensure parts are free from contaminants and sterilized properly.Improper sterilization could lead to patient harms related to the incorrect use of the device as well as adverse tissue reaction and infection.Visual inspection is sufficient.The feature has no influence on the complaint.Label: (visual comparison of the article number, lot number with the number from the work order).Legibility / quality of the label.Ensuring correct product identification and important information for use.Incorrect product labeling could lead to patient harms related to the incorrect use of the device as well as adverse tissue reaction and infection.Visual inspection is sufficient.It is not relevant for the reported complaint condition and will be not evaluated.The feature has no influence on the complaint.Packaging: (visual comparison of the packaging used with the number of the packaging reported in the bill of materials).Quality of the packaging.Ensure through a visual check that the product is packed in the appropriate packaging as well as the packaging quality.The packaging is important to guarantee that the product is safely delivered to the customers.The complaint relevant critical features were verified on the complaint part (see report).All measurements of the received plate were found to be in specification.No deviations were found in the dimensional inspection.Functional assessment: a function test could not be performed by the device.No screw was returned for the function test, therefore it is not possible to perform the test.All dimensions and the condition of the device have met the requirements, it can be assumed that the functionality of the device is guaranteed.Document / specification review: current and manufactured were reviewed.No design issues or discrepancies were identified.The ctq features were inspected and documented as part of dhr.The following raw material was used to produce this plate: part number: 60010149, lot number: 3l92900 "strip 2.9 x 300 x 1000mm 316l crs".The incoming raw material inspection has been verified.The form "deviation of raw material deliveries" was filled in due to the deviation of the material thickness.According to the assessment, the deviation has no negative influence on the quality and functionality of the products.The raw material control sheet meets the requirements.Investigation conclusion: the returned plate with article number: 241.901 (3.5mm lcp® proximal humerus plate-standard 3h shaft / 90mm) with the lot number: 5l84390 shows no breakages or other damages.The device had some cosmetic scratches that are consistent with implantation / explantation and would not have contributed to the reported complaint condition.All critical to quality features considered relevant to the product complaint were remeasured and have found to be in specification.The device history records was reviewed including the review of the documented measurements during production.All values have found to be in specification.No ncrs were generated during the manufacture of the product.Review of the dhrs showed that there were no issues during the manufacture of the product that would contribute to this reported complaint condition.No manufacturing related issues were observed during investigation.Complaint: (b)(4) is not valid from a manufacturing production point of view.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: a4; b7; d4; d6; h4.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b6, b7: subsequent follow-up with the customer, additional information was received regarding the event.Therefore, the tests/lab data including dates and medical history/preexisting condition have been updated accordingly.H10: correction narrative: d4: the udi has been updated to reflect the correct information.6a, 6b: upon complaint review, it was determined that the implantation and explantation dates were inadvertently left blank on the previous report (follow-up number 7); and have been updated accordingly.G3: upon complaint review, it was determined that the date received by manufacturer on the previous report was incorrectly reported as 7/14/2019.The correct date was 8/10/2020.H6: type of investigation, investigation findings and conclusions have been updated accordingly.H10: the investigation summary has been updated as follows: investigation flow: functional/device interaction & damage visual inspection: the titanium plate was received on july 21, 2020.The decontamination form was attached as hard copy.The plate is identified as article number 241.901 (3.5mm lcp® proximal humerus plate-standard 3h shaft/90mm) with the lot number 5l84390.Upon visual inspection, the device had some cosmetic scratches that are consistent with implantation/explantation and would not have contributed to the reported complaint condition.The reference drawings are visible in image 1.Device failure/defect identified? yes.Dimensional inspection: according to the product quality plan (pqp) for the product in scope (b)(4) ¿pqp x41.901 - x41.903¿ revision ad the following features are listed as critical to quality (ctq).See also the hole reference drawing (b)(4).Ctq relevant for reported complaint condition hole positions and angles ensure hole position and angles to match with bone geometry.It is relevant for the reported complaint condition and will be evaluated.Thread specification and position ensure thread specification of plate threading properly with its appropriate screws.It is relevant for the reported complaint condition and will be evaluated.Guide block mating holes diameter ensure hole diameter perfectly mates with the guiding block.It is relevant for the reported complaint condition and will be evaluated.Plate thickness ensure plate thickness to avoid breakages while handling.The feature has no influence on the complaint.Check ball height ensure check ball height to avoid protrusion of screw head.The ctq feature is relevant for the reported complaint condition and will be evaluated.Locking thread zero gage line ensure locking thread zero gage line to determine starting point of thread form.It is relevant for the reported complaint condition and will be evaluated.Etching ensuring correct product identification and proper function of device.Incorrect marking of the device could lead to patient harms related to incorrect use of the device.The feature ¿etching¿ has no influence on the complaint.Raw material ensuring product biocompatibility, functionality, mechanical strength, and ability to be cleaned/ reprocessed.Incorrect material could lead to patient harms related to the mechanical performance of the device as well as adverse tissue reaction and infection.Visual inspection is sufficient.It is not relevant for the reported complaint condition and will be not evaluated.The feature has no influence on the complaint suture holes edge chamfer / round ensure edge chamfer to avoid complication during procedures.It is not relevant for the reported complaint condition and will be not evaluated.The feature has no influence on the complaint.Sterility of sterile offered products maintain sterility of products to ensure parts are free from contaminants and sterilized properly.Improper sterilization could lead to patient harms related to the incorrect use of the device as well as adverse tissue reaction and infection.Visual inspection is sufficient.The feature has no influence on the complaint.Label (visual comparison of the article number, lot number with the number from the work order).Legibility / quality of the label.Ensuring correct product identification and important information for use.Incorrect product labeling could lead to patient harms related to the incorrect use of the device as well as adverse tissue reaction and infection.Visual inspection is sufficient.It is not relevant for the reported complaint condition and will be not evaluated.The feature has no influence on the complaint.Packaging (visual comparison of the packaging used with the number of the packaging reported in the bill of materials).Quality of the packaging.Ensure through a visual check that the product is packed in the appropriate packaging as well as the packaging quality.The packaging is important to guarantee that the product is safely delivered to the customers.The complaint relevant critical features were verified on the complaint part (see report).All measurements of the received plate were found to be in specification.No deviations were found in the dimensional inspection.Functional assessment a function test could not be performed by the device.No screw was returned for the function test, therefore it is not possible to perform the test.All dimensions and the condition of the device have met the requirements, it can be assumed that the functionality of the device is guaranteed.Document / specification review se_197632 rev f (current and manufactured) was reviewed.No design issues or discrepancies were identified.The ctq features were inspected and documented as part of dhr (see report) the following raw material was used to produce this plate: part number 60010149, lot number 3l92900 "strip 2.9 x 300 x 1000mm 316l crs".The incoming raw material inspection has been verified.The form "deviation of raw material deliveries" was filled in due to the deviation of the material thickness.According to the assessment, the deviation has no negative influence on the quality and functionality of the products.The raw material control sheet meets the requirements.See attachment 1 for details.Investigation conclusion: the returned plate with article number 241.901 (3.5mm lcp® proximal humerus plate-standard 3h shaft/90mm) with the lot number 5l84390 shows no breakages or other damages.The device had some cosmetic scratches that are consistent with implantation/explantation and would not have contributed to the reported complaint condition.All critical to quality features considered relevant to the product complaint were remeasured and have found to be in specification.The device history records was reviewed including the review of the documented measurements during production.All values have found to be in specification.No ncrs were generated during the manufacture of the product.Review of the dhrs showed that there were no issues during the manufacture of the product that would contribute to this reported complaint condition.No manufacturing related issues were observed during investigation.Complaint (b)(4) is not valid from a manufacturing production point of view.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history review: a manufacturing record evaluation was performed for the part: 241.901, lot: 5l84390; and no non-conformances were identified.
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