MAUDE Adverse Event Report: Synthes GmbH HAND PIECE FOR BATTERY POWERED DRIVER; Instr,Surgical,Orthopedic,AC- Powered motor/access & attach

Catalog Number	05.000.008
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was found during routine testing that device stopped working.There was no patient involvement.It was reported that there was no further information regarding the issue.All available information has been disclosed.No further information was provided.
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.H3, h6: product investigation summary: service and repair evaluation: the customer reported that 05.000.008 it was found during routine testing that device stopped working.The repair technician reported that preventive maintenance was required; some components of the device were damaged, foreign substances were observed on the protector and on some parts of the device and motor, the motor provided insufficient power, and the electrical cable was discolored.The cause of the issue was user error.The item will be repaired, put through final inspection, and will be returned to the customer upon completion of the service and repair process.The evaluation was confirmed.The device was deemed serviceable and will be returned to the customer, no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.H3, h4, h6: device history record (dhr) review conducted: part # 05.000.008 synthes lot # 008549.Supplier lot # 008549.Release to warehouse date: 31 jan 2024.Expiration date; na.Supplier: (b)(4).No ncr's generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: HAND PIECE FOR BATTERY POWERED DRIVER
• Common Device Name: Instr,Surgical,Orthopedic,AC- Powered motor/access & attach
• 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 wrights lane east; west chester, PA 19380 ; +1(908)386-3534
• MDR Report Key: 50774506
• Report Number: 8030965-2026-09375
• Device Sequence Number: 21204423
• Product Code: HWE
• UDI-Device Identifier: 10887587024585
• UDI-Public: (01)10887587024585(10)008549
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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: 05.000.008
• Device Lot Number: 008549
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/31/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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