BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SHAFT

    MDR report key: 5529884 · Received March 28, 2016

    Report

    Report Number
    2530088-2016-10092
    Event Type
    Malfunction
    Date Received
    March 28, 2016
    Date of Event
    March 10, 2016
    Report Date
    March 11, 2016
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION SUMMARY - THE COMPLAINT CONDITION FOR THE 314.23 LOT NUMBER 4061384 CANNULATED HEXAGONAL SCREWDRIVER SHAFT WAS LIKELY CAUSED BY OVER FIFTEEN YEARS OF WEAR AND CONSISTENT USE; HOWEVER, THIS COMPLAINT IS NOT LIKELY A RESULT OF ANY DESIGN RELATED DEFICIENCY. THE 314.23 CANNULATED HEXAGONAL SCREWDRIVER SHAFT IS AN INSTRUMENT ROUTINELY USED IN THE 6.5MM AND 7.3MM CANNULATED SCREWS SYSTEM. THE DEVICE WAS RETURNED AND REPORTED TO HAVE BROKEN DURING SURGERY. THIS CONDITION IS CONFIRMED; THERE IS A ROUGH FRACTURE SURFACE AT THE MOST DISTAL STEP WHERE THE HEX PORTION OF THE DEVICE BEGINS. IT IS LIKELY THAT OVER FIFTEEN YEARS OF WEAR AND CONSISTENT USE HAS LED TO THIS COMPLAINT CONDITION. THE DEVICE WAS MANUFACTURED IN 10/2000 AND IS OVER FIFTEEN YEARS OLD. THE BALANCE OF THE RETURNED DEVICE IS IN FAIRLY WORN CONDITION WITH SEVERAL MARKINGS ALONG ITS LENGTH. DEVICE DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    (B)(6). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE DHR REVIEW FOR PART#314.23 LOT#4061384, RELEASE TO WAREHOUSE DATE: 18OCT2000 , MANUFACTURED BY (B)(4) WAS WRITTEN FOR PART#314.23 LOT#4061384 FOR OVERSIZE D4 FEATURE. THE LOT WAS REWORKED (BUFF OFF ETCH, ELECTROPOLISH TO SIZE, ETCH, PASSIVATE, INSPECT 100%) AND ALL PARTS PASSED INSPECTION AND WERE ACCEPTED. THIS NON-CONFORMANCE IS NOT RELEVANT TO THIS COMPLAINT AS AN OVERSIZED OUTSIDE DIAMETER FEATURE WOULD NOT CONTRIBUTE TO THE DEVICE BREAKING AT ITS TIP. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS 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 AS THE SURGEON WAS INSERTING A CANNULATED SCREW, THE TIP OF THE HEXAGONAL SCREWDRIVER BROKE OFF. THE SURGERY WAS SUCCESSFULLY COMPLETED USING A HAND SCREWDRIVER. A DELAY OF APPROXIMATELY ONE MINUTE WAS INCURRED AS THE TIP OF THE SCREWDRIVER WAS RETRIEVED. THIS COMPLAINT INVOLVES ONE DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185878 CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SHAFT SCREWDRIVERS HXX SYNTHES BRANDYWINE 4061384

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR