BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED CRUCIFORM SCREWDRIVER

    MDR report key: 6055852 · Received October 25, 2016

    Report

    Report Number
    1719045-2016-10781
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Date of Event
    September 22, 2016
    Report Date
    October 3, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE USED IN A VETERINARY CASE - NO PATIENT INFORMATION WILL BE REPORTED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT: DHR REVIEW FOR PART # 314.463 LOT: 9972967, DHR REVIEW FOR PART#314.463 LOT#9972967, RELEASE TO WAREHOUSE DATE: 11-AUG-2016, SUPPLIER: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD 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.

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (CANNULATED CRUCIFORM SCREWDRIVER), PART NUMBER 314.463, LOT NUMBER 9972967. THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING THAT THE CRUCIFORM TIP IS PARTIALLY BROKEN. THE TIP FRAGMENTS WERE NOT RETURNED. THE HANDLE IS INTACT AND UNDAMAGED. THE RETURNED DEVICE IS INDEED BROKEN AS DESCRIBED IN THE COMPLAINT DESCRIPTION. THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A VISUAL INSPECTION AT THE BROKEN SURFACE AND THE TIP SHOWED WEAR AND TEAR SIGNS, ESPECIALLY AT THE INNER SITE OF THE TIP. UNFORTUNATELY WE ONLY HAVE LIMITED INFORMATION IN THE COMPLAINT DESCRIPTION AND CANNOT CONFIRM HOW THIS HAPPENED. DUE TO THE WEAR AND TEAR SIGNS WE ASSUME THAT THE SCREWDRIVER WAS PROBABLY NOT POSITIONED ALIGNED INTO A SCREW RECESS. BY THIS THE FORCE WAS NOT ALLOCATED ON THE WHOLE SCREW RECESS SO THAT THE ONLY ONE PART OF THE TIP GOT BROKEN. BECAUSE OF THE DAMAGE, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED. FINALLY WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. FOREIGN AND HEALTH PROFESSIONAL WERE CHECKED. 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 A VETERINARIAN REPORTED THAT A SCREWDRIVER FOR CANNULATED SCREWS BROKE DURING AN INTERVENTION. ONE OF THE TEETH OF THE SCREWDRIVER BROKE DURING THE TIGHTENING. THIS IS A SCREWDRIVER HE HAD RECENTLY PURCHASED. NO IMPACT ON PATIENT. COMPLAINT INVOLVES 1 PART. A HCS SCREW AND SCREWDRIVER WERE USED INSTEAD TO COMPLETE THE SURGERY. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706364 CANNULATED CRUCIFORM SCREWDRIVER SCREWDRIVERS HXX SYNTHES MONUMENT 9972967

    Patients

    Seq Age Sex Outcome Treatment
    1