MAUDE Adverse Event Report: SYNTHES GMBH BATTERY OSCILLATOR II FOR BPL II; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number	530.710
Medical Device Problem Codes	Mechanical Jam (2983); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
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: the actual device was returned for evaluation.However, since the investigation is still on-going, the assignable root cause could not be determined at this time.Once the investigation has been completed, a follow-up report will be submitted accordingly.
Event or Problem Description
It was reported that during service and evaluation, it was determined that the battery oscillator device had a sticky trigger, the saw head could not be rotated or locked in a new position and had component damage ¿ saw blade coupling thread.It was noted that the equipment had difficulty in coupling and uncoupling the saw.It was further determined that the device failed pretest for check for correct clamping nut, check quick coupling for saw blades, check positioning of saw head, check for sticky trigger, and check oscillation frequency with frequency meter.It was noted in the service order that the mountain road was locked.The handpiece was jammed.This event did not occur during surgery.There were no reports of injuries, medical intervention, or prolonged hospitalization.The exact date of the event was not reported; however, it was reported that the event occurred in (b)(6) of 2026.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: BATTERY OSCILLATOR II FOR BPL II
• 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 ; SZ ; 9083863534
• MDR Report Key: 25537013
• Report Number: 8030965-2026-06288
• Device Sequence Number: 9174860
• Product Code: GEY
• UDI-Device Identifier: 07611819491847
• UDI-Public: (01)07611819491847
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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

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: 530.710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2026
• Supplement Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 06/17/2026
• Supplement Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2022
• 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