BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERED U-JOINT DRIVER FOR SYNFIX MINI-OPEN

    MDR report key: 3132782 · Received May 29, 2013

    Report

    Report Number
    8030965-2013-02422
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 2, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    MAX
    PMA / PMN Number
    K072253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF EVENT UNKNOWN. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE WAS ORIGINALLY RECEIVED ON MAY 9, 2013. THE DEVICE WAS RETURNED BECAUSE THE INTERFACE BETWEEN THE SCREWDRIVER AND THE HEAD OF THE SCREW ON THE SCREWDRIVER THREADS BENT AND WOULD NOT HOLD A SCREW ONCE BENT. THE DEVICE WAS RECEIVED AT SERVICE REPAIR WHO CONDUCTED A VISUAL EVALUATION AND DETERMINED THE DEVICE COULD NOT BE REPAIRED. THE DEVICE WAS DISCARDED. THERE IS NO FURTHER INFORMATION AVAILABLE FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE WAS RECEIVED BENT. SERVICE HISTORY OF THE PAST THREE YEARS HAS BEEN REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES CONSULTANT, DURING SURGERY ON AN UNKNOWN DATE WHILE PERFORMING FINAL TIGHTENING DURING THE SURGERY, THE INTERFACE BETWEEN THE SCREWDRIVER AND THE HEAD OF THE SCREW ON THE SCREWDRIVER THREADS BENT AND WOULD NOT HOLD THE SCREW. THIS IS 1 OF 1 DEVICE FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235395 TAPERED U-JOINT DRIVER FOR SYNFIX MINI-OPEN MAX SYNTHES GMBH 8006068

    Patients

    Seq Age Sex Outcome Treatment
    1