MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HANDLE FOR 90° SCREWDRIVER; DRILL, BONE, POWERED

Model Number 03.505.004

Device Problem Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional device product codes: dzj, hxx.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 an unknown date, threads on 90 degree drill handpiece are stripped, the shaft for 90-degree driver would not thread on.It did thread onto a different handpiece though.There was no patient involvement.Concomitant device reported: unknown screwdriver shaft (part #: unknown, lot #: unknown, quantity #: 1).This report is for one (1) handle for 90 degree screwdriver.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.The handpiece for 90-degree screwdriver (part # 03.505.004, lot # 8140696, mfg # 15-may-2014) was received with the distal threads stripped.This is consistent with the reported complaint condition, thus confirming the complaint.A dimensional inspection was not performed as the complaint was able to be visually confirmed.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot: part: 03.505.004.Lot: 8140696.Manufacturing site: selzach.Supplier: diener ag precision machining.Release to warehouse date: 15.May 2014.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: HANDLE FOR 90° SCREWDRIVER
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8655073
• MDR Text Key: 146638475
• Report Number: 2939274-2019-58388
• Device Sequence Number: 1
• Product Code: DZI
• UDI-Device Identifier: 10887587013305
• UDI-Public: (01)10887587013305
• Combination Product (y/n): N
• PMA/PMN Number: K082649
• 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: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.505.004
• Device Catalogue Number: 03.505.004
• Device Lot Number: 8140696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Initial Date Manufacturer Received: 05/01/2019
• Initial Date FDA Received: 05/30/2019
• Supplement Dates Manufacturer Received: 06/04/2019
• Supplement Dates FDA Received: 06/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - SCREWDRIVERS: SHAFTS