MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC COMBINATION T-WRENCH 8MM

Model Number	392.969
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Only event year is known.Reporter is a synthes employee.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 a procedure it was noted that the t-handle wrench for medium external fixator broke while applying clamps for an ex-fix frame.A ratchet wrench was used instead of t-handle wrench to complete the procedure.There were fragments generated but removed easily without additional intervention.There was no surgical delay and the procedure was successfully completed.There were no patient consequences noted.This report involves one (1) combination t-wrench 8mm.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- this complaint was confirmed as the device was received broken.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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 history lot : part # 392.969, synthes lot # 4804572, supplier lot # na, release to warehouse date: 03nov2004, manufactured by synthes brandywine.The material was reviewed and the hardness value was confirmed to meet the specification with no (relevant) non-conformance noted.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 condition.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 T-WRENCH 8MM
• Common Device Name: WRENCH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12919320
• Report Number: 2939274-2021-06920
• Device Sequence Number: 4994803
• Product Code: HXC
• UDI-Device Identifier: 10886982198921
• UDI-Public: (01)10886982198921
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2021

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: 392.969
• Device Catalogue Number: 392.969
• Device Lot Number: 4804572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 11/04/2021
• Supplement Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 12/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2004
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - EX-FIX CLAMPS
• Patient Sex: Unknown