BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE WITH QUICK COUPLING, SMALL

    MDR report key: 6133271 · Received November 29, 2016

    Report

    Report Number
    1719045-2016-10866
    Event Type
    Malfunction
    Date Received
    November 29, 2016
    Date of Event
    November 4, 2016
    Report Date
    November 4, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION WAS NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE SUBJECT DEVICE IS CURRENTLY UNDERGOING INVESTIGATION; THE RESULTS ARE PENDING COMPLETION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. MANUFACTURER: SYNTHES MONUMENT, SUPPLIER: (B)(4). DATE OF MANUFACTURE: JAN 28, 2015. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. 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

    NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS PART NUMBER 311.43 WITH LOT NUMBER(S) 7893396 IS A LOT/BATCH CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS JANUARY 28, 2015. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. A PRODUCT INVESTIGATION WAS COMPLETED: THE DEVICE WAS SENT TO CUSTOMER QUALITY WHERE IT WAS EXAMINED AND THE DEVICE WAS FOUND TO BE BROKEN AT THE COUPLING SHAFT. THIS DEVICE WAS MANUFACTURED PRIOR A DESIGN CHANGE TO ADDRESSED THE BREAKAGE OF THE BLUE RADEL HANDLES (EFFECTIVE MARCH 07, 2016). IT WAS DETERMINED THAT THE DESIGN TOLERANCE OF THE DEVICE RESULTED IN PRESS FITS BETWEEN THE HANDLE BORE AND COUPLING SHAFT AND THE DOWEL PIN HOLE AND DOWEL PIN. THESE TOLERANCES WERE SHOWN TO BE TOO TIGHT FOR THE PRESS FIT BETWEEN THE STAINLESS STEEL SHAFTS AND THE PPSU HOLES IN THE HANDLE. THE INTERFERENCE FITS GENERATE INTERNAL STRESSES THAT CAN LEAD TO THE HANDLES CRACKING, BREAKING DURING USE, AND BREAKING WITHIN THE PACKAGE. THEREFORE, THE ROOT CAUSE OF THE HANDLES CRACKING AND BREAKING IS THE TOLERANCES TOO TIGHT FOR PRESS FIT WHICH IS CLASSIFIED AS A DIMENSIONAL INTERACTION. THIS IS THE LIKELY CAUSE OF THIS COMPLAINT CONDITION. DURING THE INVESTIGATION NO UNIDENTIFIED PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THIS COMPLAINT IS CONFIRMED. THE HANDLE WITH QUICK COUPLING, SMALL (311.43) IS ALSO A COMMON INSTRUMENT, NOTED IN 45 SYSTEM TECHNIQUE GUIDES INCLUDING: COMPACT DISTAL RADIUS, COMPACT FOREFOOT RECONSTRUCTION SCREW AND 2.4MM CANNULATED SCREWS. IN EACH SYSTEM THE DRIVER IS UTILIZED WITH AN ACCOMPANYING SCREWDRIVER SHAFT FOR SCREW INSERTION. RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENT WERE REVIEWED (BOTH FROM THE TIME OF MANUFACTURE AND PRESENT REVISION): TOP-LEVEL AND HANDLE. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE RETURNED INSTRUMENT¿S LOT NUMBER AND NO MATERIAL REVIEW REPORTS, NON-CONFORMANCE REPORTS OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBER WHICH 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.

    Description of Event or Problem · 1

    IT WAS REPORTED A HANDLE WITH QUICK COUPLING, SMALL BROKE DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE, FOR THE ELBOW, ON (B)(6) 2016. WHILE INSERTING A LOCKING SCREW, THE HANDLE BROKE INTO TWO PIECES. THE BROKEN PIECES DID NOT FALL INTO THE PATIENT'S BODY. NO MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACKUP HANDLE. THERE WAS NO PATIENT HARM REPORTED AND THE MALFUNCTION CAUSED A ONE (1) MINUTE DELAY. PATIENT STATUS/OUTCOME WAS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: LOCKING SCREW (QTY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781942 HANDLE WITH QUICK COUPLING, SMALL TAP, BONE HWX SYNTHES MONUMENT 7893396

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN LOCKING SCREW, QTY 1