MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SHAFT; SCREWDRIVERS

Catalog Number 314.23

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

There is no patient involvement.Date of event: it is unknown when the device became stripped.Device is an instrument and is not implanted/explanted.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.A device history records review has been requested.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 three malfunctioning devices were discovered during routine inspection.The tip of a cannulated 4.0 mm hexagonal screwdriver is stripped.A torque limiting attachment is broken in half (and is in two pieces) at the junction point.A stardrive screwdriver shaft t8 is stuck together inside the torque limiting attachment.There is no known procedure involvement.This report is for a cannulated 4.0mm hexagonal screwdriver shaft.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.Device history record (dhr) review: part number: 314.23; lot number: 4326205; date of manufacture: november 15, 2001; place of manufacture: brandywine plant, nemco medical; part expiration date: n/a; list of nonconformances: n/a; description of dhr review: no nonconformance records (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint action.Review of raw material certificate showed that there were no issues with the raw material used to manufacture the device that would contribute to this complaint action.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint action.Customer quality investigation: the following investigations were performed: broken.Visual inspection- visual inspection performed at customer quality (cq) of the returned device confirmed the broken tip condition, which agrees with the reported complaint condition.The returned device hex tip was broken off at its tip base and broken fragments were not returned at customer quality.No other issues were identified on the remaining portions of the device.Dimensional analysis and document/specification review: product drawings for cannulated hex screw driver shaft were reviewed during this investigation.No product design issues or discrepancies were observed.A relevant dimensional inspection could not be performed at customer quality due to the significant post manufacture damage in the form of broken fragments that were not returned at customer quality.Review of the device history record(s) showed that the complaint device was manufactured in november 2001.Review of raw material certificate showed that there were no issues with the raw material used to manufacture the device that would contribute to this complaint action.Based off the dhr review it was observed that no ncrs were generated during manufacture of the product that would contribute to this complaint condition.Conclusion- a definitive root cause for the tip breakage could not be determined from the provided information.However, it is likely that the device being in service for over 16 years and any unintended excessive forces during usage/handling could have contributed to this complaint condition.This complaint is confirmed; however, no product design issues or manufacturing discrepancies were identified during this investigation based on the investigation findings, it has been determined that no corrective and/or preventative 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: CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SHAFT
• Type of Device: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7592744
• MDR Text Key: 110872932
• Report Number: 2939274-2018-52467
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10886982188700
• UDI-Public: (01)10886982188700
• 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: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 314.23
• Device Lot Number: 4326205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Date Manufacturer Received: 07/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1