MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC COMBINATION WRENCH 11MM/BLADE SCREW; MISC ORTHO SURGICAL INSTR

Model Number	03.037.031
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: flow: damage.Visual inspection: the instrument was received at us cq and upon inspection a portion of the jaw broke off and was not returned.No other issues were identified.A device failure was identified.Dimensional inspection: a dimensional inspection was done due to post manufacturing damage.Document/specification review: based on the review of the related drawings, no design issues contributing to relevant complaint condition were identified.Conclusion: no definitive root cause was able to be determined as the circumstances surrounding the complaint are unknown, excessive force was applied while attempting to separate the tfna helical blade from extractor.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: part: 03.037.031, lot: 9921641, manufacturing site: umkirch, release to warehouse date: may.06, 2016.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.
Event or Problem Description
It was reported that on january 25, 2020 at the sterile processing, the wrench broke while trying to disengage the trochanteric femoral nail advanced (tfna) helical blade from extractor.There was no patient involvement.Concomitant device reported: unknown tfna helical blade (part # unknown, lot # unknown, quantity # 1), unknown extractor (part # unknown, lot # unknown, quantity # 1).This complaint involves one (1) device.This is 1 of 1 for report (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.H10 additional narrative: 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: COMBINATION WRENCH 11MM/BLADE SCREW
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9859730
• Report Number: 2939274-2020-01397
• Device Sequence Number: 2663777
• Product Code: LXH
• UDI-Device Identifier: 10886982070470
• UDI-Public: (01)10886982070470
• Combination Product (Y/N): N
• 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): 03/10/2020

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 Model Number: 03.037.031
• Device Catalogue Number: 03.037.031
• Device Lot Number: 9921641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 03/23/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - EXTRACTION INSTRUMENTS: TRAUMA; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE