BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RATCHETING SCREWDRIVER HANDLE

    MDR report key: 15959462 · Received December 12, 2022

    Report

    Report Number
    8030965-2022-10922
    Event Type
    Malfunction
    Date Received
    December 12, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    UDI-DI
    10887587035673
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL PROCODE: LXH. REPORTER IS A SYNTHES EMPLOYEE. PART: 311.023. SYNTHES LOT:# 6089022. SUPPLIER LOT: T931675. RELEASE TO WAREHOUSE DATE: FEBRUARY 19, 2009. SUPPLIER: SYNTHES TUTTLINGEN. NO NONCONFORMANCE REPORTS (NCRS) WERE 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. SERVICE AND REPAIR EVALUATION: THE CUSTOMER REPORTED THAT 311.023, RATCHETING SCREWDRIVER HANDLE SWITCH DID NOT WORK. THE REPAIR TECHNICIAN REPORTED THAT THE SWITCH WAS CEASED, QUICK COUPLING FAILED TO LOCK INTO ATTACHMENT, THUMB LATCH FAILED TO WORK IN FORWARD, REVERSE AND LOCK MODE, AND DEVICE FAILED TO OPERATE SMOOTHLY. TOTAL REBUILD NEEDED IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE RATCHETING SCREWDRIVER HANDLE SWITCH DID NOT WORK. IT IS UNKNOWN WHEN THE ISSUE WAS OBSERVED. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. UPON MANUFACTURER INVESTIGATION, IT WAS DETERMINED THAT THE SWITCH WAS CEASED, QUICK COUPLING FAILED TO LOCK INTO ATTACHMENT, THUMB LATCH FAILED TO WORK IN FORWARD, REVERSE AND LOCK MODE, AND DEVICE FAILED TO OPERATE SMOOTHLY. THIS REPORT IS FOR A RATCHETING SCREWDRIVER HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2298278 RATCHETING SCREWDRIVER HANDLE SCREWDRIVER HXX SYNTHES GMBH 311.023 10887587035673

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown