MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC COMBINATION WRENCH 11MM/BLADE SCREW; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	03.037.031
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is a synthes employee.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 unknown date, during routine inspection it was observed that the combination wrench was broken.There was no known patient or hospital involvement.This report is for a combination wrench.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.H3, h4, h6: dhr review for the following device was conducted at manufacturing site umkirch by site lead quality assurance part # 03.037.031-us, lot # l238093.Manufacturing date: 27 dec, 2016.A dhr review was performed for the finished device lot number and the production was according to the requirements and no non-conformance was identified.The material used was according to specification and within production there was no deviation detected.Visual inspection: the combination wrench 11mm/blade screw (p/n: 03.037.031, lot #: 83p9271) was returned and received at us customer quality (cq).Upon visual inspection, the wrench was observed to be broken at one of the tip.The broken components were not returned.No other issues were identified.Device failure/defect identified? yes.Dimensional inspection: measured dimensions: thickness of the wrench: (conforming).Measuring device: ca802.Document/specification review: the following documents were reviewed: wrench hexagonal 11/blade/screw: (current and manufactured) no design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion the complaint condition was confirmed for the returned devices.No definitive root cause could be determined based on the provided information.The unintended external forces might have contributed to the reported complaint condition.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12225633
• Report Number: 2939274-2021-04272
• Device Sequence Number: 5244540
• Product Code: LXH
• UDI-Device Identifier: 10886982070470
• UDI-Public: (01)10886982070470
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2021

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: L238093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 07/26/2021
• Supplement Report FDA Received Date: 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1