BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE BATTERY POWERED DRIVER

    MDR report key: 22940174 · Received September 2, 2025

    Report

    Report Number
    8030965-2025-08911
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    July 21, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    UDI-DI
    10887587024585
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. INVESTIGATION SUMMARY: SERVICE AND REPAIR EVALUATION: THE CUSTOMER REPORTED ¿IT WAS REPORTED THAT THE 05.000.008 BUTTONS SOMETIMES RESPOND FINE BUT WILL STOP WORKING IF HELD FOR MORE THAN 4 SECONDS. THE ISSUE WAS OBSERVED DURING PRE-OP. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.¿ THE REPAIR TECHNICIAN REPORTED BUTTON FAILURE IN CIRCUIT BOARD, CORROSION/RUSTING/PITTING IN MOTOR AND FOREIGN SUBSTANCE/DEBRIS/CLEANING/STERILIZATION IN PROTECTOR/SHIELD. THE CAUSE OF THE ISSUE IS IMPROPER MAINTENANCE. THE ITEM WILL BE REPAIRED, PUT THROUGH FINAL INSPECTION, AND WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. FINALIZED SERVICE RECORD WILL BE ARCHIVED IN MDS&R. 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. DEVICE HISTORY: PART# 05.000.008, SYNTHES LOT# 6118012, SUPPLIER LOT# 002579, RELEASE TO WAREHOUSE DATE: 01.APR.2009. SUPPLIER: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 05.000.008 BUTTONS SOMETIMES RESPOND FINE BUT WILL STOP WORKING IF HELD FOR MORE THAN 4 SECONDS. THE ISSUE WAS OBSERVED DURING PRE-OP. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2150715 HANDLE BATTERY POWERED DRIVER INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES GMBH 002579 10887587024585

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown