MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS; GUIDE

Model Number	357.411
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/13/2019
Type of Reportable Event	Serious Injury
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 (b)(6) 2019, during insertion of cannulated trochanteric fixation nail (tfn), difficulty was encountered upon drilling through the 130-degree aiming arm.The drill bit collided with the tfn implant.The result was additional drill holes in the femur.The procedure was extended approximately 20 minutes.Additional c-arm time was required.The locking screw was successfully inserted in the locking option.The inner drill sleeves were removed, and the drill bit was then used to drill through both cortices in a freehand technique.There were no fragments generated.There was a surgical delay approximately twenty (20) minutes.Procedure was successfully completed.No patient consequence.Concomitant device reported: unknown locking screws (part # unknown, lot # unknown, quantity 1).This is report 1 for (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.Part: 357.411.Synthes lot: 5241618/5358673.Supplier lot: n/a.Release to warehouse date: november 21, 2006.Expiration date: n/a.Manufactured by synthes brandywine.There are no relevant nonconformances.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Visual inspection of the returned insertion handle revealed surface wear consistent with use.The device's etching was slightly discolored, but still legible.This issue is consistent with use, and qualifies as failure due to normal wear.No other damage or defect was noted.The device lied flat on a flat surface.No distortion, warping, deformation was observed.Functional test testing of the complaint condition could not be performed as the only other device returned was the aiming arm (product code 357.366; lot 8070897).The insertion handle and aiming arm were able to be assembled per specification.No issues were observed with this construct.The complaint could not be replicated with the returned device.Dimensional inspection.Specification: handle proximal-distal length.Result: conforming.Specification: handle medial-lateral thickness.Result: conforming.Specification: nail alignment tab feature height.Result: conforming.Document/specification review no design issues were identified.Conclusion: the complaint could not be confirmed during investigation.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Per guidance, it is determined that the reusable instrument device's etch is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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/TROCHANTERIC FIXATION NAILS
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8983851
• Report Number: 2939274-2019-60418
• Device Sequence Number: 3323713
• Product Code: FZX
• UDI-Device Identifier: 10886982196347
• UDI-Public: (01)10886982196347
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 357.411
• Device Catalogue Number: 357.411
• Device Lot Number: 5241618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 10/11/2019
• 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: UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Weight: 84