BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER SHAFT T8 55MM

    MDR report key: 6104711 · Received November 15, 2016

    Report

    Report Number
    3003875359-2016-10594
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    October 25, 2016
    Report Date
    October 25, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. CONCOMITANT DEVICES - L052737 (VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L16 TA SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT: DHR REVIEW FOR: PART 314.453 & LOT. 9890675 MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 20 APRIL 2016. NO NCR'S WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. 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: THE MANUFACTURER INVESTIGATION RESULTS ARE AS FOLLOWS. THE TIP FO THE SCREWDRIVER SHAFT STARDRIVE 2.4, SHORT IS ROUNDED AND WORN. THE MANUFACTURING REVIEW, OF ALL ABOVE MENTIONED DEVICES, SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    ADDITIONAL NARRATIVE: 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

    DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT FOR THE FIRST TIME, THE REPORTED DEVICES WERE USED IN SURGERY FOR THE DISTAL HUMERAL FRACTURES ON (B)(6) 2016. THE SURGEON SELECTED THREE HOLES LOCATED ON THE REAR OUTSIDE OF THE PLATE. HE INSERTED ONE CORTEX SCREW INTO THE SHAFT DURING THE CONFIRMATION OF THE PARTS OUTSIDE THE PATIENT. NEXT, HE TRIED TO INSERT THE REPORTED VA LOCKING SCREW 16MM INTO THE MOST DISTAL HOLE. THEN, THE LOCKING SCREW WAS NOT FIXED AND IDLED. THE SURGEON TOOK THE SCREW OUT OF THE PLATE. HE MOUNTED THE DRILL GUIDE ONTO THE DRILLING UNIT AGAIN. HE TRIED RE-DRILLING AND SCREW INSERTION BUT THE SCREW WAS NOT LOCKED AGAIN, SO ANOTHER SCREW WAS USED. ALTHOUGH THE SURGEON DID NOT FEEL ENOUGH TORQUE ON THE SCREW, IT WAS FIXED IN THE HOLE TO A CERTAIN EXTENT. HE THEN MOVED ON TO THE NEXT SCREW INSERTION. AT THAT TIME, EIGHT SCREWS WERE FIXED ON THE ORIGINAL PLATE (LOCATED THE REAR OUTSIDE) AND AN ADDITIONAL INNER PLATE. WHEN HE TRIED TO FIRMLY FIX SIX OUT OF THE EIGHT SCREWS, THE SCREW DRIVER CAME OFF THE SCREWS. ACCORDING TO THE SURGEONS COMMENT, THE VALUE OF THE TORQUE LIMITATION MIGHT HAVE BEEN TOO HIGH. THERE WAS A SURGICAL PROLONGATION OF 15 MINUTES. CONCOMITANT DEVICE: 1X 04.211.016S / L052737 (VA LOCKSCR O2.7 HEAD 2.4 SELF-TAP L16 TA) 8X UNK SCREW THIS REPORT IS 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL CONCOMITANT PART: UNKNOWN PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753994 STARDRIVE SCREWDRIVER SHAFT T8 55MM SCREWDRIVERS HXX SYNTHES HAGENDORF 9890675

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)| 8X UNK SCREWS