MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC AIMING ARM FOR ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX; GUIDE, SURGICAL, INSTRUMENT

Model Number	03.010.227
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is an unknown date in 2021.Part: 03.010.227.Lot: l929353.Supplier lot: na.Release to warehouse date: december 18, 2018.Manufacturer: (b)(4).No nonconformance reports (ncrs) were generated during production.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the aiming arm for adolescent lfn nail-ex was received at us customer quality (cq).Visual inspection of the complaint device showed no physical apparent defect.Functional test: during the functional assessment one of the two locking cam assembly did not perform as intended.When the arm was flip to the locking position, it remained there as there was no tension in the system to pull it back to its initial position.The return spring inside the system appeared broken.Dimensional inspection: no dimensional inspection was performed due to requiring destruction of the device, and device assembly and geometry limits ability to accurately dimensionally inspect.Document/specification review: current and manufactured revisions were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the complaint device was received with broken return spring which did not allow the gold tension/targeting arm to function as intended.However, the reported condition as missing can not be confirmed.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 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 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
Device report from synthes (b)(4) reports an event as follows: it was reported one of the gold handles on targeting arm for the recon screws from the alfn is missing a spring; therefore, it is not able to lock the recon sleeve correctly.Additionally, the connecting screw threads are stripped.There was no patient consequence.Upon manufacturer investigation, it was determined that the aiming arm was broken.This report is for an aiming arm for adolescent lateral entry femoral nail.This is report 2 of 2 for (b)(4).

• Brand Name: AIMING ARM FOR ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12554507
• Report Number: 2939274-2021-05808
• Device Sequence Number: 872460
• Product Code: FZX
• UDI-Device Identifier: 10886982068095
• UDI-Public: (01)10886982068095
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2021

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: 03.010.227
• Device Catalogue Number: 03.010.227
• Device Lot Number: L929353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1