MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS; GUIDE

Model Number	357.366
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
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 2 for 5 (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: 357.366-us.Lot: 8070897.Manufacturing site: hägendorf.Release to warehouse date: october 25, 2012.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection of the returned aiming arm revealed scratches and nicks, which are consistent with use.A nick on the edge of the medial opening of the head element aperture displaced material into the opening.No other damage or defect was noted.Functional test testing of the complaint condition could not be performed as the only other device returned was the insertion handle (product code 357.411; lot 5241618).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 devices.Dimensional inspection: specification: aiming arm locking bolt aperture.Result: conforming.Specification: aiming arm head element aperture.Result: nonconforming.The guide sleeve (product code 357.369) is the largest mating instrument that passes through the head element aperture.Per the guide sleeve's shaft's outer diameter specification, the nonconforming dimension would not cause an interference issue affecting the assembly of the constructs or performance of the devices.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.The noted nick was attributed to rough handling and/or use of the device, and was determined to have not contributed to the complaint condition.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: 130 DEG AIMING ARM 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: 8983859
• Report Number: 2939274-2019-60421
• Device Sequence Number: 13522008
• Product Code: FZX
• UDI-Device Identifier: 10886982196019
• UDI-Public: (01)10886982196019
• 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: 357.366
• Device Catalogue Number: 357.366
• Device Lot Number: 8070897
• 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