MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RAD AIMING ARM/FRN GREATER TROCHANTER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 03.033.003

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/06/2021

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 Description

It was reported that on (b)(6) 2021, the superior locking clip on the femoral recon nails greater trochanteric aiming arm broke off and was not able to lock unknown superior recon screw cannula into aiming arm.Fragments were retained.Procedure was completed successfully without any surgical delay.Concomitant device reported: unk, screw: (part# unknown; lot# unknown; quantity: unknown).This report is for (1) radiolucent aiming arm/frn greater trochanter.This is report 1 of 1 for complaint (b)(4).

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, h4, h6: part (b)(4), lot l862674: manufacturing site: hagendorf.Release to warehouse date: august 21, 2018.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.H3, h6: a product investigation was completed: visual inspection of the complaint device showed one of the locking clips had broken off.A dimensional inspection was not performed due to post-manufacturing damage.The current and manufactured to drawing was reviewed; no design issues or discrepancies were identified.This complaint is confirmed as one of the locking clips had broken off.No photos or xrays were returned to show an embedded device.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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: RAD AIMING ARM/FRN GREATER TROCHANTER
• Type of Device: 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: 12080433
• MDR Text Key: 262457725
• Report Number: 2939274-2021-03276
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982271075
• UDI-Public: (01)10886982271075
• Combination Product (y/n): N
• PMA/PMN Number: K172157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.033.003
• Device Catalogue Number: 03.033.003
• Device Lot Number: L862674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Date Manufacturer Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: TRAUMA.
• Patient Age: 69 YR