MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA SCREW 85MM - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.038.085
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that on an unknown date during routine incoming inspection, it was observed that the trochanteric femoral nail advanced (tfna) screw was stuck together with the helical blade/ screw extractor.There was no patient involvement.This report is for one (1) tfna screw 85mm.This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Depuy synthos 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 synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: additional information: d4 e3: reporter is a synthes employee.H3, h4, h6: part number: 04.038.085s lot number: 7909576 part manufacturing date: february 10, 2015 manufacturing site: elmira part expiration date: december 31, 2024.Nonconformance noted: n/a a review of the device history record revealed no complaint related anomalies.The device history record shows lot 7909576 of tfna screws was processed through the normal manufacturing and inspection operations with no rework or nonconformance's noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record(s) determined the raw material lot 7818863 met all specifications with no issues documented that would contribute to this complaint condition.A review of the device history record revealed no complaint related anomalies.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.Visual inspection: the tfna screw 85mm (p/n: 04.038.085, lot number: 7909576) was received at us customer quality (cq).Visual inspection of the complaint device it is stuck to a mating device (03.037.030) and unable to disassemble, rather than unable to assemble.Additionally, the exterior is scratched/nicked.Functional test: a functional assessment was performed with the complaint device.The complaint device could not be disassembled from the returned mating device.The complaint condition can be replicated.Dimensional inspection: no dimensional inspection was performed due to device received condition.Document/specification review: current) and manufactured were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the complaint device cannot be disassembled from the returned mating device.Additionally, the exterior is scratched/nicked.No root cause could definitively be determined for the reported complaint condition.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 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.
Additional Manufacturer Narrative
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: part number: 04.038.085s, lot number: 7909576, part manufacturing date: february 10, 2015, manufacturing site: elmira, part expiration date: december 31, 2024, nonconformance noted: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows lot 7909576 of tfna screws was processed through the normal manufacturing and inspection operations with no rework or nonconformances noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record(s) determined the raw material lot 7818863 met all specifications with no issues documented that would contribute to this complaint condition.A review of the device history record revealed no complaint related anomalies.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.Visual inspection: the tfna screw 85mm (p/n: 04.038.085, lot number: 7909576) was received at us customer quality (cq).Visual inspection of the complaint device it is stuck to a mating device (03.037.030) and unable to disassemble, rather than unable to assemble.Additionally, the exterior is scratched/nicked.Functional test: a functional assessment was performed with the complaint device.The complaint device could not be disassembled from the returned mating device.The complaint condition can be replicated.Dimensional inspection: no dimensional inspection was performed due to device received condition.Document/specification review: current and manufactured were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the complaint device cannot be disassembled from the returned mating device.Additionally, the exterior is scratched/nicked.No root cause could definitively be determined for the reported complaint condition.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 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.

• Brand Name: TFNA SCREW 85MM - STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9977541
• Report Number: 2939274-2020-01927
• Device Sequence Number: 19657313
• Product Code: HSB
• UDI-Device Identifier: 10886982098443
• UDI-Public: (01)10886982098443
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: 04.038.085
• Device Catalogue Number: 04.038.085S
• Device Lot Number: 7909576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2020
• Initial Date Received by Manufacturer: 03/27/2020
• Supplement Date Received by Manufacturer: 05/04/2020; 05/12/2020
• Initial Report FDA Received Date: 04/20/2020
• Supplement Report FDA Received Date: 05/05/2020; 05/13/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HELICAL BLADE/SCREW EXTRACTOR; HELICAL BLADE/SCREW EXTRACTOR