BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER SHAFT T4/42MM/SELF-RETAINING

    MDR report key: 5478459 · Received March 3, 2016

    Report

    Report Number
    1719045-2016-10189
    Event Type
    Malfunction
    Date Received
    March 3, 2016
    Date of Event
    February 17, 2016
    Report Date
    February 17, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. NO PATIENT INFORMATION HAS BEEN PROVIDED. (B)(4).. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THERE WERE NO NONCONFORMANCES GENERATED DURING PRODUCTION. THE LOT WAS RELEASE TO THE WAREHOUSE ON 10/6/2009. THE WORK ORDER WAS ISSUED ON 07/13/2009 FOR QTY.(B)(4). 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 REPORT WAS INITIALLY SUBMITTED AS FOLLOW UP NUMBER 2 ON APRIL 14, 2016. RESUBMITTING INFORMATION WITH CORRECT FOLLOW UP NUMBER. ADDITIONAL NARRATIVE: ADDED THE UDI NUMBER TO THE APPLICABLE FIELD. PART 03.114.002 / LOT 6182075 WAS NOT RECEIVED, NOR IS IT EXPECTED TO BE RETURNED. IF THE DEVICE IS RETURNED, THE INVESTIGATION WILL BE UPDATED TO REFLECT THE INVESTIGATION FINDINGS. AT THIS TIME, NO EVALUATION IS ANTICIPATED. DEVICE 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

    ADDITIONAL NARRATIVE: ADDED THE UDI NUMBER TO THE APPLICABLE FIELD. CORRECTED DATA: PART 03.114.002 / LOT 6182075 WAS NOT RECEIVED, NOR IS IT EXPECTED TO BE RETURNED. IF THE DEVICE IS RETURNED, THE INVESTIGATION WILL BE UPDATED TO REFLECT THE INVESTIGATION FINDINGS. AT THIS TIME, NO EVALUATION IS ANTICIPATED. DEVICE 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 · 1

    IT WAS REPORTED THAT TWO SCREWDRIVER SHAFTS STRIPPED OUT DURING AN INITIAL SURGERY ON (B)(6) 2016. WHILE PLATING A PROXIMAL PHALANGE, THE SURGEON ATTEMPTED TO REMOVE THE PRE-ASSEMBLED DRILL GUIDE FROM THE IMPLANT, THE SCREWDRIVER "STRIPPED OUT", BEGUN SPINNING AND WOULD NOT FUNCTION. A SECOND ATTEMPT WAS MADE WITH ANOTHER GUIDE AND THIS SHAFT ALSO STRIPPED OUT AND WOULD NOT FUNCTION. THE SURGEON USED PLIERS TO COMPLETE THE SURGERY SUCCESSFULLY. THE PATIENT OUTCOME WAS UNAFFECTED BY THIS INCIDENT AND THERE WAS NO DELAY IN SURGERY REPORTED. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132946 STARDRIVE SCREWDRIVER SHAFT T4/42MM/SELF-RETAINING SCREWDRIVERS HXX SYNTHES MONUMENT 6182075

    Patients

    Seq Age Sex Outcome Treatment
    1