MAUDE Adverse Event Report: Synthes GmbH BATTERY HANDPIECE/MODULAR FOR TRS; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number	05.001.201
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during service and evaluation, it was determined that the battery handpiece device had a sticky trigger, failed the leak tightness test, the k-wire could not be inserted, the device would not hold/secure the battery, the housing was cracked/damaged, and the device had component damage.It was further determined that the device failed pretest for general condition, leakage test, check the cannulation of the handpiece, check for sticky triggers, check the roundness of the housing, and check falling out protection.It was noted in the service order that prior to an unspecified surgical procedure it was observed that the device did not work anymore.This event did not occur during a surgical procedure.There were no reports of injuries, medical intervention, or prolonged hospitalization.The exact date of the event was not reported.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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 this medwatch, a supplemental medwatch report will be filed as appropriate.H11: additional narrative: device evaluation: the actual device was returned for evaluation.The battery handpiece device was evaluated and the reported condition that the device was not working anymore was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the device had a sticky trigger.The assignable root cause of this condition was determined to be traced to component failure due to wear.

• Brand Name: BATTERY HANDPIECE/MODULAR FOR TRS
• Common Device Name: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): Synthes GmbH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: elba bello ; eimattstrasse 3; oberdorf 04436 ; SZ 04436 ; +1(908)386-3534
• MDR Report Key: 50858026
• Report Number: 8030965-2026-09643
• Device Sequence Number: 13138627
• Product Code: GEY
• UDI-Device Identifier: 07611819977815
• UDI-Public: (01)07611819977815
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• 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: 05.001.201
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/28/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2017
• 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