MAUDE Adverse Event Report: SYNTHES GMBH 10NM TORQUE WRENCH 11MM ACROSS THE FLATS

Catalog Number	388.261
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary the product was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed that the 10nm torque wrench.Exhibits signs of normal use.No cosmetic defects were observed on the surface.The allegation of loose was not observed during the torque test.A dimensional inspection was not performed as it is not applicable to the complaint condition.A functional test was performed using torque meter.Torque handle is required to deliver 10.0 ¿ 11.0 nm at intermediate setting.Actual measured values range from 9.47 - 9.86 nm.The complaint condition was able to be replicated as it resulted in under torquing.The overall complaint was confirmed as the observed condition of the 10nm torque wrench would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Dimensional inspection: n/a.Device history part #388.261.Synthes lot #j002942.Supplier lot #j002942.Release to warehouse date: 19 apr 2021.Manufacturing site: s.S.White medical products i.No ncrs were generated during production.
Event or Problem Description
It was reported on (b)(6) 2026, that, the symphony torque handles were feeling loose.Procedure was completed successfully with an unknown surgical delay.(b)(4) and (b)(4) are related to each other.

• Brand Name: 10NM TORQUE WRENCH 11MM ACROSS THE FLATS
• Common Device Name: WRENCH
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 25278797
• Report Number: 8030965-2026-04841
• Device Sequence Number: 18586208
• Product Code: HXC
• UDI-Device Identifier: 10705034772233
• UDI-Public: (01)10705034772233(10)J002942
• Combination Product (Y/N): N
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 388.261
• Device Lot Number: J002942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2021
• 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
• Patient Sex: Unknown