MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5MM HEX FLEXIBLE SCREWDRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 03.037.028

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2020

Event Type  malfunction  

Manufacturer Narrative

Reporter is a j&j sales representative.The device has been 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 Description

It was reported that on (b)(6) 2020, during an unknown procedure when the interlocking mechanism on the trochanteric fixation nail advanced (tfna) was locked with the 5.0 cannulated hexagonal screwdriver, the hexagonal flexible screwdriver was snapped.There was no delay in procedure and the screwdriver remained together although broken.Procedure was successfully completed.There is no patient consequence.Concomitant devices reported: unknown nail head elements: tfna helical blade (part# unknown, lot# unknown, quantity 1), unknown nails: tfna (part# unknown, lot# unknown, quantity 1).This report is for one (1) 5mm hex flexible screwdriver.This is report 1 of 1 for (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.Visual inspection: the 5mm hex flexible screwdriver (p/n: 03.037.028, lot number: 9298605) was received at us cq.Visual inspection of the complaint device showed the shaft broke at the first link.Device failure/defect identified? yes.Dimensional inspection: shaft diameter (proximal) = conforming.Shaft diameter (distal) = conforming.Device used - ca215p.Document/specification review: current and manufactured were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the shaft has broken at the first link.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 history lot: part: 03.037.028.Lot: 9298605.Manufacturing site: hägendorf.Release to warehouse date: january 27, 2015.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.

• Brand Name: 5MM HEX FLEXIBLE SCREWDRIVER
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11102159
• MDR Text Key: 224592547
• Report Number: 2939274-2020-05815
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886982070449
• UDI-Public: 10886982070449
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.037.028
• Device Catalogue Number: 03.037.028
• Device Lot Number: 9298605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Date Manufacturer Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - NAILS: TFNA; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - NAILS: TFNA