BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER SHAFT T25/6MM HXC-LONG

    MDR report key: 4002412 · Received August 12, 2014

    Report

    Report Number
    1719045-2014-10361
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT EVALUATION WAS PERFORMED. (B)(4). 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.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. THE DEVICE HISTORY REVIEW FOR P/N 03.620.002, LOT 5015596, SHOWED MATERIAL REVIEW RECORD (B)(4) GENERATED FOR THE BEAD BLAST AREA STARTING CLOSER TO THE COUPLING THAN SPECIFIED. THE DISPOSITION WAS UAI FOR ALL THE DRIVERS. THE NONCONFORMANCE IS NOT RELEVANT TO THE COMPLAINT CONDITION BECAUSE THE HEX COUPLING AREA IS UNRELATED TO THE TIP BEING WORN / STRIPPED AND WOULD ONLY POTENTIALLY AFFECT THE HANDLE MATING. THE REVIEW OF THE RAW MATERIAL DHR FOR P/N 11156, LOT 4770533, SHOWED NO NONCONFORMANCES GENERATED DURING PRODUCTION AND NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A POSTERIOR CERVICAL FUSION PROCEDURE, THE SURGEON WAS PERFORMING THE FINAL TIGHTENING ON A SCREW AT LEVEL T1. WHILE USING THE STARDRIVE SCREWDRIVER FOR THE SYNAPSE SYSTEM THE DRIVER SLIPPED AND STRIPPED. THERE WAS A 5 MINUTE DELAY IN SURGERY. UPON FURTHER REVIEW ANOTHER SCREWDRIVER WAS FOUND TO HAVE THE SAME MALFUNCTION. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477957 STARDRIVE SCREWDRIVER SHAFT T25/6MM HXC-LONG SCREWDRIVER HXX SYNTHES MONUMENT 5015596

    Patients

    Seq Age Sex Outcome Treatment
    1