MAUDE Adverse Event Report: SYNTHES GMBH TORQUE LIMITING ATTACHMENT 4.0NM FOR TRS; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	05.001.216
Medical Device Problem Codes	Mechanical Jam (2983); Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The device 05.001.213, 05.001.216 was submitted from affiliate in switzerland and following condition(s) were reported: device does not work anymore.The event involved 2 devices.The malfunction has been reported to have occurred during: pre-op.Reported injuries: who was involved (e.G.Patient, user, etc., ¿vet¿ if it was a veterinary device) unknown.Surgery delay: no report of surgery delay has been made at this time.Medical intervention: no report of medical intervention has been made at this time.Other information on the surgery/event: what device(s) and how many devices were involved in the event.Product information (name family, and/ or code), load status if required unknown, the outcome of the event, outcome to the patient(s) and/or users (e.G.Artificial anus, prolonged operation time, blood transfusion) unknown, how was the surgery ended (with same like device, similar product, sutured by hand etc) unknown.If any additional information should became available, the note section will be updated accordingly.Products reported under (b)(4) needs to be returned to the respective analysis site for the service to be performed.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.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.H11 additional narrative: investigation summary: a visual and functional assessment was performed on the device: the following steps failed: check general function in running mode.During the service evaluation the following failures were identified: functional: frozen/will not move.Conclusion: failure reported is confirmed.Root cause: faulty parts.Action: return unrepaired.
Event or Problem Description
It was reported that during service and evaluation, it was determined that the attachment device was frozen/would not move.It was noted in the service order that the device did not work anymore.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention, or prolonged hospitalization.All available information has been disclosed.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.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.Corrected data b5: event description has been updated.

• Brand Name: TORQUE LIMITING ATTACHMENT 4.0NM FOR TRS
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: elba bello ; eimattstrasse 3; oberdorf 04436 ; SZ 04436 ; 9083863534
• MDR Report Key: 24578440
• Report Number: 8030965-2026-02450
• Device Sequence Number: 21421542
• Product Code: HWE
• UDI-Device Identifier: 07611819977945
• UDI-Public: (01)07611819977945(20)15
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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: 05.001.216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2023
• 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