BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAR/HEXDRIVE SCREWDRIVER T25 3.5MM HEX/SELF-RETAINING

    MDR report key: 5546913 · Received April 5, 2016

    Report

    Report Number
    1719045-2016-10293
    Event Type
    Malfunction
    Date Received
    April 5, 2016
    Date of Event
    March 21, 2016
    Report Date
    March 21, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS COMPLETED: ONE STAR/HEXDRIVE SCREWDRIVER T25 3.5MM HEX/SELF-RETAINING (PART 03.010.150, LOT 7053223) WAS RECEIVED AT CUSTOMER QUALITY (CQ) FOR EVALUATION. THIS COMPLAINT IS CONFIRMED, AS THE RETURNED DEVICE WAS RECEIVED AT CQ WITH THE DISTAL TIP SHEARED OFF. THE REMAINING DISTAL TIP IS TWISTED APPROXIMATELY 35 DEGREES IN THE DIRECTION OF SCREW REMOVAL. THE SHEARED OFF TIP WAS NOT RETURNED FOR EVALUATION. WHETHER THIS COMPLAINT CAN BE REPLICATED IS NOT APPLICABLE AS THE DEVICE IS ALREADY BROKEN. UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. PER THE COMPLAINT DESCRIPTION, THE RETURNED DEVICE TIP BROKE WHILE REMOVING AN IMPLANTED SCREW (IMPLANTED FOR APPROXIMATELY 3 MONTHS). THEREFORE, THE COMPLAINT CONDITION WAS MOST LIKELY CAUSED BY SCREW REMOVAL TORQUE EXCEEDING THE STRENGTH OF THE SCREWDRIVER SHAFT TIP GEOMETRY DUE TO BONY INGROWTH IN AND AROUND THE IMPLANTED SCREW. IT IS NOT LIKELY THAT THE DESIGN OF THE INSTRUMENT CONTRIBUTED TO THIS COMPLAINT. A VISUAL INSPECTION, DEVICE HISTORY RECORD (DHR) REVIEW, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. TOP LEVEL ASSEMBLY DRAWING AND SCREWDRIVER SHAFT COMPONENT DRAWING WERE REVIEWED DURING THIS EVALUATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED, IT DID NOT CONTRIBUTE 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

    ADDITIONAL NARRATIVE: PATIENT INITIALS: (B)(6). PATIENT EXACT WEIGHT WAS REPORTED AS (B)(6). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: OCTOBER 09, 2012. PART 03.010.150, LOT 7053223: 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. 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 THE TIP OF A SCREWDRIVER BROKE OFF DURING A LEFT DISTAL FEMUR HARDWARE REMOVAL DUE TO NON-UNION. THE PATIENT WAS ORIGINALLY IMPLANTED WITH A NON-SYNTHES HARDWARE (PLATE AND SCREWS) APPROXIMATELY NINE MONTHS PRIOR. THE TIP OF THE STAR/HEXDRIVE SCREWDRIVER T25 3.5MM HEX/SELF-RETAINING BROKE OFF AS A DISTAL LOCKING SCREW WAS EXPLANTED. THE BROKEN TIP CAME OUT IN THE HEAD OF A SCREW AND WAS RETRIEVED. NO FRAGMENTS REMAINED IN THE PATIENT. THERE WAS A REPORTED SURGICAL DELAY OF LESS THAN TWENTY SECONDS. ANOTHER SCREWDRIVER WAS READILY AVAILABLE FOR USE. THE PATIENT WAS REVISED TO A VARIABLE ANGLE CONDYLAR PLATE AND SCREWS. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT AND WITH THE PATIENT IN STABLE CONDITION. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203273 STAR/HEXDRIVE SCREWDRIVER T25 3.5MM HEX/SELF-RETAINING SCREWDRIVERS HXX SYNTHES MONUMENT 7053223

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR