BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE WITH MINI QUICK COUPLING

    MDR report key: 6262490 · Received January 18, 2017

    Report

    Report Number
    2530088-2017-10022
    Event Type
    Malfunction
    Date Received
    January 18, 2017
    Date of Event
    December 30, 2016
    Report Date
    December 30, 2016
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HWX
    UDI-DI
    10886982187192
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED. THE 311.01 LOT NUMBER 4931074 HANDLE WITH MINI QUICK COUPLING WAS RETURNED AND REPORTED TO HAVE BROKEN DURING SURGERY. THIS COMPLAINT CONDITION WAS LIKELY CAUSED BY OVER TWELVE YEARS OF CONSISTENT USE AND POSSIBLE ROUGH HANDLING DURING SURGERY OR STERILE PROCESSING; HOWEVER, THIS COMPLAINT IS NOT LIKELY A RESULT OF ANY DESIGN OR MANUFACTURING RELATED DEFICIENCY. A VISUAL INSPECTION, DEVICE HISTORY RECORD (DHR) REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THIS COMPLAINT IS CONFIRMED. AS PER TECHNIQUE GUIDE, THE 311.01 HANDLE WITH MINI QUICK COUPLING IS AN INSTRUMENT ROUTINELY USED IN THE SCREW REMOVAL SET. THE DEVICE WAS RETURNED AND REPORTED TO HAVE BECOME BROKEN DURING SURGERY. THIS CONDITION IS CONFIRMED; THE PHENOLIC HANDLE HAS BROKEN INTO THREE SEPARATE PIECES AND THE METAL COUPLING HAS FALLEN OUT. THE DEVICE WAS MANUFACTURED IN 1/2005 AND IS OVER TWELVE YEARS OLD. THE BALANCE OF THE RETURNED DEVICE IS IN FAIRLY WORN CONDITION. RELEVANT DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. THE CONDITION OF THE RETURNED DEVICE DOES AGREE WITH THE COMPLAINT DESCRIPTION. WHETHER THE COMPLAINT CONDITION FOR THIS DEVICE CAN BE REPLICATED IS NOT APPLICABLE FOR THIS CONDITION. IT IS LIKELY THAT OVER TWELVE YEARS OF CONSISTENT USE AND POSSIBLE ROUGH HANDLING DURING SURGERY OR STERILE PROCESSING HAS LED TO THIS COMPLAINT CONDITION. 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

    (B)(6). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. PART 311.01.96, LOT 4931074: RELEASE TO WAREHOUSE DATE: JANUARY 24, 2005. SUPPLIER: (B)(4). NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A LEFT CLAVICLE, THE HANDLE WITH MINI QUICK COUPLING (SCREWDRIVER HANDLE) BROKE DURING SURGERY ON (B)(6) 2016. THE SURGEON HAD JUST COMPLETED SUCCESSFUL INSERTION OF ONE OF THE FINAL SCREWS AND THE HANDLE WAS TAKEN TO THE BACK TABLE, WHERE IT FELL APART. THE HANDLE SPLIT IN HALF, CREATING THREE PIECES. THE SPLITTING OF THE HANDLE DID NOT GENERATE ANY FRAGMENTS. THE HANDLE APPEARED TO BE INTACT DURING SCREW INSERTION. THE SURGEON WAS ABLE TO INSERT THE SCREW WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT HARM, SURGICAL DELAY OR NEED FOR ADDITIONAL MEDICAL INTERVENTION. ROUTINE INTRAOPERATIVE X-RAYS WERE TAKEN AS STANDARD FOR THE PROCEDURE. IT IS UNKNOWN WHICH SCREW WAS BEING INSERTED WHEN THE HANDLE WAS PLACED ON THE BACK TABLE AND FELL APART. IT WAS EITHER A 2.0MM CORTEX SCREW 14MM OR 2.0MM CORTEX SCREW 16MM. CONCOMITANT MEDICAL PRODUCTS: EITHER 2.0MM CORTEX SCREW, 14MM (PART 201.364.97, LOT UNKNOWN, QUANTITY 1); OR 2.0MM CORTEX SCREW, 16MM (PART 201.366.97, LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44474 HANDLE WITH MINI QUICK COUPLING TAP, BONE HWX SYNTHES BRANDYWINE 4931074 10886982187192

    Patients

    Seq Age Sex Outcome Treatment
    1 1 2.0MM CORTEX SCREW