BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED 4.0MM HEXAGONAL SCREWDRIVER

    MDR report key: 3951228 · Received July 22, 2014

    Report

    Report Number
    3003875359-2014-10217
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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: A PRODUCT EVALUATION WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT THE: CANNULATED HEXAGONAL SCREWDRIVER FOR 7.3MM CANNULATED SCREW (314.050 / LOT # 3482907 / MFG LOCATION: (B)(4)/ MFG. DATE: 03/2011). THE BROWN HANDLE HAS MINOR MARKS FROM ROUTINE USE, BUT IS OTHERWISE IN EXCELLENT CONDITION WITH NO DISCERNABLE ISSUES. THE RETURNED DEVICE SHOWS LIGHT USE DURING ITS 3 YEAR LIFESPAN. DRAWING (B)(4) FOR THE INSTRUMENT(S) WAS REVIEWED AND IS DETERMINED TO BE SUITABLE FOR THE DESIGN AND RELATED DIMENSIONAL CONFORMITY. THE RETURNED INSTRUMENT(S) ARE USED TO INSERT 7.3MM CANNULATED SCREWS, AND PROPER USE AND MAINTENANCE ARE ADDRESSED IN TECHNIQUE GUIDE (B)(4). THE RETURNED DEVICE IS MULTI USE AND IS ONE OF TWO METHODS FOR INSERTING 7.3MM CANNULATED SCREW. SINCE NO DISCERNABLE ISSUES ARE PRESENT AND NO ADDITIONAL INFORMATION IS AVAILABLE, THIS COMPLAINT IS UNCONFIRMED. DUE TO INSUFFICIENT INFORMATION AND THE INABILITY TO REPLICATE THE COMPLAINT CONDITION WITH THE DEVICE, THE EXACT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. THIS COMPLAINT CONDITION IS MOST LIKELY A RESULT OF METHOD OF USE AND NOT THE DEVICE'S DESIGN. BECAUSE OF THIS, THE COMPLAINT IS DETERMINED NOT TO BE A DESIGN DEFICIENCY. THE RETURNED PART(S) ARE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED. THIS COMPLAINT IS UNCONFIRMED, AND THE DESIGN OF THE DEVICE DID NOT CONTRIBUTE TO THIS COMPLAINT. 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 OPEN REDUCTION INTERNAL FIXATION (ORIF) WHILE REMOVAL OF A SCREW THE SCREWDRIVER BROKE. IT WAS ALSO REPORTED THAT WHILE VIEWING AN X-RAY TAKEN DURING SURGERY, THE SURGEON DISCOVERED THAT ONE OF THE THREE SCREWS WAS TOO LONG. WHILE REMOVING THE ONE LONG SCREW, THE SCREWDRIVER WAS BROKE FROM HANDLE AND THERE WERE NO FRAGMENTS. SURGERY WAS COMPLETED SUCCESSFULLY WITH ANOTHER SCREWDRIVER. THERE WERE NO REPORTS OF A SURGICAL DELAY. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427858 CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SCREWDRIVERS HXX SYNTHES HAGENDORF 3482907

    Patients

    Seq Age Sex Outcome Treatment
    1