BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0MM BIHEXAGONAL SCREWDRIVER WITH T-HANDLE

    MDR report key: 4116995 · Received September 25, 2014

    Report

    Report Number
    3003875359-2014-10287
    Event Type
    Malfunction
    Date Received
    September 25, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 14, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THERE NO NCRS WERE GENERATED DURING PRODUCTION. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AS PART OF THE MANUFACTURING INVESTIGATION REPORTED THE SCREWDRIVER IN PERFECT CONDITION. THE SCREWDRIVER SHAFT SHOWED SIGNS OF USE BUT WAS IN PERFECT FUNCTIONAL CONDITION. A FUNCTIONAL TEST WAS CARRIED OUT AND IT WAS POSSIBLE TO INSERT AND REMOVE EACH SCREWDRIVER FROM THE HEAD OF THE SCREW RETURNED. THIS IS INDICATIVE OF A LITTLE RESISTANCE WAS FELT UPON REMOVAL, BUT THIS IS NORMAL AS THE SCREWDRIVER'S TIP ENGAGES THE HEAD OF A SCREW TO PREVENT SCREW FALLING OFF DURING USE. LOT 8132549 WAS MANUFACTURED IN OCTOBER 2012 MEETING ALL SPECIFICATIONS. NO PRODUCT FAULT COULD BE FOUND. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE COMPLAINT RECEIVED STATES THAT THE POLYAXIAL SCREW IN QUESTION DID NOT SEPARATE FROM THE SCREW DRIVER IN INSERTION. THERE WAS A 30 MINUTE SURGICAL DELAY. THIS IS REPORT NUMBER 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598124 3.0MM BIHEXAGONAL SCREWDRIVER WITH T-HANDLE SCREWDRIVERS HXX SYNTHES HAGENDORF 8132549

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR