MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC HEXAGONAL SCREWDRIVER

Catalog Number	314.75
Medical Device Problem Codes	Break (1069); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: device was used for treatment, not diagnosis.No patient information available for reporting.Malfunction was discovered intraoperatively but it is unknown when the malfunction occurred.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.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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
(b)(4) reported that during tibial fracture procedure on (b)(6) 2018, screw driver head was found to be broken and wouldn't grip enough to insert locking bolt during locking steps of expert nail insertion.No patient harm noted.There was no delay in procedure and procedure was completed successfully.Patient reported as fine.Concomitant devices reported: locking bolt (part # 459.58, lot # unknown, qty 1).(b)(4).
Additional Manufacturer Narrative
Additional narrative: lot number, udi number.The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.Corrected data: physical manufacturer.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.
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.Additional narrative: a device history record (dhr) review was performed for part # 314.75 , synthes lot # 4600563 , supplier lot # na , release to warehouse date: 09 jul 2003 , manufactured by synthes brandywine: no non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.A product investigation was performed.The returned hex screw driver (part: 314.75, lot: 4600563, mfg: 09 jul 2003) was inspected at customer quality and the complaint of broken was not confirmed but the device was observed to be stripped.Therefore the overall complaint condition was confirmed.Upon visual inspection, it is observed that the hex tip was worn and stripped.Additionally, the handle was observed with dent at the etched portion of device.No new malfunctions have been identified.Whether this complaint could be replicated is not applicable as the device was returned damaged.Relevant drawings for the returned device were reviewed (both current and from the time of manufacture): top-level drawing for hex screw driver ,314_75(rev.E to rev.F), screw driver shaft 314_75_1(rev.C to rev.D) and no design issues or discrepancies were noted.Dimensional analysis performed at the hex corner to corner dimensions measured 3.86 mm (ca 814) that falls within the specification of 3.85 mm to 3.95 mm based on 314_75_1,rev.C(dco-0798031).Also, dimensional analysis performed at hex flat to flat measured 3.5 mm (ca 814) that falls within specification of 3.48 mm to 3.5 mm.Based on the device history record review, there is no indication that any issues with material or material properties contributed to the complaint condition.While no definitive root cause could be determined it is possible that the age of the device and any unintended forces encountered during device usage could have contributed to the complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.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: HEXAGONAL SCREWDRIVER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7241194
• Report Number: 2939274-2018-50491
• Device Sequence Number: 10791144
• Product Code: HXX
• UDI-Device Identifier: 10886982189097
• UDI-Public: (01)10886982189097(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2018

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: 314.75
• Device Lot Number: 4600563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Initial Date Received by Manufacturer: 01/13/2018
• Supplement Date Received by Manufacturer: 02/13/2018; 04/04/2018
• Initial Report FDA Received Date: 02/05/2018
• Supplement Report FDA Received Date: 02/13/2018; 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1