MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC INSERTION HANDLE F/ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX; MISC ORTHO SURGICAL INSTR

Model Number	03.010.226
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 as no product was received.The investigation could not be completed, no product was received; 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 (b)(6) 2020, it is unable to get the 12 mm guide sleeve through the insertion handle for expert adolescent lateral femoral nail.The guide sleeve will not fit through the insertion handle.It appears that the insertion handle may have been hit with something, damaging the hole that the guide sleeve goes through.The date occurred during surgery.The patient was not impacted anyway.There was a surgical delay of 5 minutes.Procedure successfully completed.Patient outcome is unknown.This complaint involves two (2) devices this report is for (1) insertion handle f/adolescent lateral entry femoral nail-ex.This is report 1 of 2 (b)(4).
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.Device history- part: 03.010.226, lot: 1777480, manufacturing site: hägendorf, release to warehouse date: 14.Dec.2007.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.
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: visual inspection: the insertion handle f/adolescent lateral entry femoral nail-ex (part # 03.010.226 / lot # 1777480) was received at us customer quality (cq).The visual inspection of the received device indicated that a small portion of the device¿s very distal tab was broken off.No fragments were returned.Due to the broken tab, the device is inoperable.The reported device interaction may be caused due to the broken distal tab.Several nicks were observed on the device.Thus the overall complaint was confirmed.Device failure/defect identified? yes; the distal tab of the device was broken.Dimensional inspection: the dimensional inspection was not performed due to the post-manufacturing damage.Document/specification review: drawing(s) reviewed: (current & manufactured revisions).Conclusion: the overall complaint was confirmed for the received device as a small portion of the distal tab component of the device was broken off.The reported device interaction issue may be caused due to the identified broken tab condition.Although no definitive root-cause can be determined it is possible the device experienced unintended forces.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: INSERTION HANDLE F/ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10485202
• Report Number: 2939274-2020-03941
• Device Sequence Number: 1246014
• Product Code: LXH
• UDI-Device Identifier: 10886982068088
• UDI-Public: (01)10886982068088
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2020

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 Model Number: 03.010.226
• Device Catalogue Number: 03.010.226
• Device Lot Number: 1777480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Initial Date Received by Manufacturer: 08/09/2020
• Supplement Date Received by Manufacturer: 09/17/2020; 10/05/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 09/28/2020; 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 12.0MM/8.0MM PROTECTION SLEEVE 188MM