MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5MM HEX FLEXIBLE SCREWDRIVER; MISC ORTHO SURGICAL INSTR

Model Number 03.037.028

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Reporter is a synthes employee.The investigation could not be completed, no product was received; 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 an unknown date, the trigger handle for cable cutter seems to be not dealing far enough to actually cut the cables.This was realized during a product demonstration.The other device hexagonal flexible screwdriver shaft broke.This was found in sterile processing department.Concomitant device reported: unknown cables (part # unknown, lot # unknown, quantity unknown).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.H3, h6: part: 03.037.028, lot: 9298602, manufacturing site: hägendorf, release to warehouse date: 16.Jan.2015.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual investigation: the 5 mm hex flexible screwdriver (p/n: 03.037.028, lot # 9298602) was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the screwdriver was broken at the most proximal laser cut teeth segment on the shaft.The shaft was completely broken into two (2) pieces and received at us cq.There were scratches and the etch on the device started to fade which has no impact on the functionality of the device.No other issues were identified with the returned components of the device.Device failure/defect identified? yes.Dimensional inspection: the dimensional inspection was performed on the returned device.The shaft diameter of the device was measured to be within the specification as per the drawing.Document/specification review: based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed flexible screwdriver hex 5 flexible shaft.Complaint confirmed? yes, the device received was broken.Hence confirming the allegation.Conclusion: the complaint was confirmed for the 5 mm hex flexible screwdriver (p/n: 03.037.028, lot # 9298602) as the shaft of the device was completely broken.There was no indication that a design or manufacturing issue has caused the breakage and hence the root cause cannot be determined.This damage is consistent with a device that was likely subjected to the unanticipated torsional forces during the tightening process, resulting in the shaft of the screwdriver twisting and breaking off.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: 5MM HEX FLEXIBLE SCREWDRIVER
• Type of Device: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9536567
• MDR Text Key: 190763275
• Report Number: 2939274-2019-62819
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886982070449
• UDI-Public: (01)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,health
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• 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: 9298602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Date Manufacturer Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - CABLE/WIRE