| Model Number 04.124.418 |
| Device Problem
Break (1069)
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| Patient Problems
Pain (1994); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Additional device product codes: hwc and hrs.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.(b)(4).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 an unknown date that the patient underwent an unknown surgery and revealed that a titanium rod had broken in tfn.It was removed and replaced but patient still in excruciating pain.She had to undergo two additional corrective surgeries.The patient was involved in a motorcycle accident on (b)(6) 2016 and suffered from multiple injuries, including fractures to both her right and left femurs as well as right hip.On an unknown date, the patient underwent an unknown procedure where a titanium trochanteric fixation nail system (tgh) and additional markings ced/1233 and 96898 was used for intramedullary fixation of her right hip and femur.The patient has been mostly confined to wheelchair since the accident.She continues to have pain, but the corrective surgeries have lessened her pain.Concomitant devices reported: 1.7mm cable with crimp 750mm (part number 298.801, lot p233138 , quantity 3), 5.0mm variable angle lockng screw/slf-tpng/strdrv/65mm (part number 02.231.265, lot 9880865, quantity 1), 5.0mm variable angle lockng screw/slf-tpng/strdrv/70mm (part number 02.231.270, lot 9893051, quantity 1), 5.0mm variable angle lockng screw/slf-tpng/strdrv/70mm (part number 02.231.270, lot 7656403, quantity 1), 5.0mm variable angle lockng screw/slf-tpng/strdrv/34mm (part number 02.231.234, lot 9763945, quantity 1), 5.0mm variable angle lockng screw/slf-tpng/strdrv/34mm (part number 02.231.234, lot 9880864, quantity 1), screws: trauma (part number unknown, lot unknown, quantity 3), nails: tfn (part number unknown, lot unknown, quantity 1), this report involves one (1) 4.5mm ti va-lcp crvd condylar plate/18 hole/370mm/right.This is report 2 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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Product complaint # (b)(4).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, h4, h6: device history lot part number: 04.124.418, synthes lot number: 9688980, manufacturing site: mezzovico, release to warehouse date: 20.Oct.2015.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Investigation summary: background: it was reported that on or around (b)(6) 2016, as the patient was rolled over in bed onto her right side, she felt her right leg "pop".She was in excruciating pain and was transferred to er.The patient underwent an unknown surgery and revealed that a titanium rod had broken in tfn.It was removed and replaced.The patient was discharged to a skilled nursing facility for additional physical therapy.She continued to have extreme pain, much worse than before the rod broke.She had to undergo two additional corrective surgeries.On (b)(6) 2016, the patient was involved in a motorcycle accident and suffered multiple serious surgeries, including fractures to both her right and left femurs and her right hip.On an unknown date, the patient underwent an unknown procedure where a titanium trochanteric fixation nail system (tgh) and additional markings ced/1233 and 96898 was used for intramedullary fixation of her right hip and femur.The patient was discharged to a skilled nursing facility and was then transferred to a similar facility during (b)(6) 2016.She was then discharged to her home but continued with physical therapy.The patient has been mostly confined to wheelchair since the accident.She continues to have pain, but the corrective surgeries have lessened her pain.This complaint involves one (1) device.Note: due to unknown discoloration observed on the broken plate, the device was evaluated by the material science engineer.The investigation performed on the nature of the unknown discoloration.Investigation flow: damage.Visual inspection: the 4.5mm ti va-lcp crvd condylar plate/18 hole/370mm/right (p/n: 04.124.418, lot number: 9688980) was received at us cq.Upon visual inspection, the plate was broken into two distinct pieces.The breakage occurred on the va-6 hole.Unknown discoloration was observed in some area of the holes where screws were used.Light scratches were also observed on the surface of the device and those are expected due to implantation and explanation (cosmetic).Device failure/defect identified since the plate was broken into two pieces.Dimensional inspection: device used: hand micrometer om521.Document/specification review: current and manufactured drawings were reviewed.No design issues or discrepancies were identified.Material testing: the broken plate was examined for evidence of fretting and corrosion.Neither broken piece of the plate could be examined using energy dispersive spectroscopy (eds) device due to the size constraints of the microscope.While eds or sem examination of the discoloration on the plate could not be performed, the presence of such discoloration on the flat surface of the plate, away from any fretting or other features, suggests that this material was likewise not corrosive product or material.On the basis of these observations, no significant corrosion was noted on the plate.Minor fretting was observed on each of the received broken plate pieces.Complaint was confirmed.Investigation conclusion: this complaint is confirmed for the 4.5mm ti va-lcp crvd condylar plate/18 hole/370mm/right (p/n: 04.124.418, lot number: 9688980) as the visual inspection confirmed the complete breakage of the plate.Also the visual inspection revealed fretting around some holes where the screws were used on the plate.No definitive root cause could be determined based on the provided information and the investigation but it is likely that the breakage was due to the device experiencing extreme forces.The fretting observed could likely due to the stainless steel implants coming into contact and experiencing motion which removes the passive layer on the surface of the implant which enables the fretting.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.If additional information is made available, the investigation will be updated as applicable.
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Manufacturer Narrative
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Product complaint # (b)(4).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.B7: updated additional information provided for reporting.Investigation summary: background: it was reported that on or around (b)(6) 2016, as the patient was rolled over in bed onto her right side, she felt her right leg "pop".She was in excruciating pain and was transferred to er.The patient underwent an unknown surgery and revealed that a titanium rod had broken in tfn.It was removed and replaced.The patient was discharged to a skilled nursing facility for additional physical therapy.She continued to have extreme pain, much worse than before the rod broke.She had to undergo two additional corrective surgeries.On (b)(6) 2016, the patient was involved in a motorcycle accident and suffered multiple serious surgeries, including fractures to both her right and left femurs and her right hip.On an unknown date, the patient underwent an unknown procedure where a titanium trochanteric fixation nail system (tgh) and additional markings ced/1233 and 96898 was used for intramedullary fixation of her right hip and femur.The patient was discharged to a skilled nursing facility and was then transferred to a similar facility during (b)(6)2016.She was then discharged to her home but continued with physical therapy.The patient has been mostly confined to wheelchair since the accident.She continues to have pain, but the corrective surgeries have lessened her pain.This complaint involves one (1) device.Note: due to unknown discoloration observed on the broken plate, the device was evaluated by the material science engineer.Investigation flow: damage.Visual inspection: the 4.5mm ti va-lcp crvd condylar plate/18 hole/370mm/right (p/n: 04.124.418, lot number: 9688980) was received at us cq.Upon visual inspection, the plate was broken into two distinct pieces.The breakage occurred on the va-6 hole.Unknown discoloration was observed in some area of the holes where screws were used.Light scratches were also observed on the surface of the device and those are expected due to implantation and explantation (cosmetic).Device failure/defect was identified.The plate was broken into two pieces.Document/specification review: se_366691 rev h and g (current and manufactured to) drawings were reviewed.No design issues or discrepancies were identified.Material testing: the broken plate was examined for evidence of fretting and corrosion.Neither broken piece of the plate could be examined using energy dispersive spectroscopy (eds) device due to the size constraints of the microscope.While eds or sem examination of the discoloration on the plate could not be performed, the presence of such discoloration on the flat surface of the plate, away from any fretting or other features, suggests that this material was likewise not corrosive product or material.On the basis of these observations, no significant corrosion was noted on the plate.Minor fretting was observed on each of the received broken plate pieces.Complaint was confirmed.Investigation conclusion: this complaint is confirmed for the 4.5mm ti va-lcp crvd condylar plate/18 hole/370mm/right (p/n: 04.124.418, lot number: 9688980) as the visual inspection confirmed the complete breakage of the plate.Also the visual inspection revealed fretting around some holes where the screws were used on the plate.No definitive root cause could be determined based on the provided information and the investigation but it is likely that the breakage was due to the device experiencing extreme forces.The fretting observed could likely due to the stainless steel implants coming into contact and experiencing motion which removes the passive layer on the surface of the implant which enables the fretting.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.H3, h4, h6: device history lot: part number: 04.124.418, synthes lot number: 9688980, manufacturing site: mezzovico, release to warehouse date: 20.Oct.2015.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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, h4, h6: part 02.124.418, lot 9688980: manufacturing site: mezzovico.Release to warehouse date: october 20, 2015.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: b4 - date of this report b7 - medical history/preexisting condition.H4 - device manufacture date.H6 - codes updated to imdrf codes.Note: due to unknown discoloration observed on the broken plate, the device was evaluated by the material science engineer.Please see attached "(b)(4) materials & product testing report (b)(4).2020" for the investigation performed on the nature of the unknown discoloration.Visual inspection: the 4.5 vacrvd condy pl/18h/370/rt (p/n: 02.124.418, lot number: 9688980) was received at us cq.Upon visual inspection, the plate was broken into two distinct pieces.The breakage occurred on the va-6 hole.Unknown discoloration was observed in some area of the holes where screws were used.Light scratches were also observed on the surface of the device and were consistent with the device usage.Dimensional inspection: drawing: se_366691 rev g specified dimensions width of plate mid shaft: 17.5 +0.5mm/-0.1mm, thickness of plate mid shaft: 5.4 +0.4mm/-0mm, measured dimensions.Width of plate mid shaft: 17.821 mm - conform.Thickness of plate mid shaft: 5.785 mm - conform.Device used: hand micrometer om521.Document/specification review: se_366691 rev h and g (current and manufactured to) drawings were reviewed.No design issues or discrepancies were identified.Material testing: the broken plate was examined for evidence of fretting and corrosion.Neither broken piece of the plate could be examined using energy dispersive spectroscopy (eds) device due to the size constraints of the microscope.While eds or sem examination of the discoloration on the plate could not be performed, the presence of such discoloration on the flat surface of the plate, away from any fretting or other features, suggests that this material was likewise not corrosive product or material.On the basis of these observations, no significant corrosion was noted on the plate.Minor fretting was observed on each of the received broken plate pieces.Investigation conclusion: this complaint is confirmed for the 4.5 vacrvd condy pl/18h/370/rt (p/n: 02.124.418, lot number: 9688980) as the visual inspection confirmed the complete breakage of the plate.Also the visual inspection revealed fretting around some holes where the screws were used on the plate.No definitive root cause could be determined based on the provided information and the investigation but it is likely that the breakage was due to the device experiencing extreme forces.The fretting observed could likely due to the stainless steel implants coming into contact and experiencing motion which removes the passive layer on the surface of the implant which enables the fretting.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive 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 lot - ncr 3246495 was generated for an engraving non-conformance found a machine.Maintenance was intensified, se_355877_ad remained valid to engrave all pieces, in correspondence to additional check the presence of the engraving for 100% completeness, uniformity and legibility.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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Search Alerts/Recalls
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