MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LARGE HEXAGONAL SCREWDRIVER 3.5MM WIDTH ACROSS FLATS; SCREWDRIVERS

Catalog Number	03.010.121
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 review of the device history records 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 or Problem Description
It was reported that during an open reduction internal fixation (orif) of the hip to implant the trochanteric fixation nail advanced (tfna) system, the surgeon experienced an issue during the procedure with the hexagonal screwdriver.The wooden handle was spinning around the shaft of the screwdriver and the surgeon was unable to insert the 5.0mm distal locking screw.Another screwdriver was used and the surgeon was able to place the locking screw.There was no surgical delay.The procedure was completed successfully and the patient was reported to be stable.Concomitant devices reported: 130 degree aiming arm screw only (part 03.037.115, lot unknown, quantity 1); 5.0mm ti locking screw 34mm - for im nails - sterile (part 458.934s, lot unknown, quantity 1).This is report 1 of 1 for (b)(4).
Additional 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.Patient ethnicity is unknown.Part: 03.010.121; synthes lot: 4865687; supplier lot: n/a; release to warehouse date: october 08, 2004; expiration date: n/a; manufactured by synthes brandywine; no nonconformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Customer quality investigation: the following investigations were performed: device interaction/functional: visual inspection: visual inspection performed on the returned hexagonal screwdriver observed the handle to be spinning when attempted to rotate against the fixed driver shaft.No new issues were observed on the other portions of the device other than minor signs of wear which would affect the product functionality.Functional inspection was not able to be performed as mating device was not returned for evaluation.However, the post manufacture loose handle condition could have possibly contributed to given complaint condition.Complaint condition was not able to be replicated as the mating device was not returned at customer quality.However, with the damage identified the complaint condition agree with the complaint description and the complaint condition was confirmed.Drawing review: based on the date of manufacture the following drawings, reflecting the current and manufactured revision, were reviewed.Top level drawing and handle drawing.Dimensional analysis and document/specification review: dimensional inspection at the relevant feature (handle cannulation) was not able to be performed as the handle stays intact with the screw driver shaft was not able to be disassembled.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Conclusion: a definitive root cause could not be determined from the provided information.However, it is likely that the age of the device (over 13 years) and device encountered any unintended forces during usage /possible rough handling could have contributed to this complaint condition.The overall complaint condition 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: LARGE HEXAGONAL SCREWDRIVER 3.5MM WIDTH ACROSS FLATS
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7652359
• Report Number: 2939274-2018-52689
• Device Sequence Number: 11174027
• Product Code: HXX
• UDI-Device Identifier: 10886982067890
• UDI-Public: (01)10886982067890
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03.010.121
• Device Lot Number: 4865687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 08/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1