BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED 4.0MM HEXAGONAL SCREWDRIVER

    MDR report key: 3812474 · Received May 15, 2014

    Report

    Report Number
    3003875359-2014-10110
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    April 19, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 NO PRODUCT WAS RECEIVED. 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 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

    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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS ADDITIONAL NARRATIVE: AN EVALUATION WAS PERFORMED ON THE RETURNED DEVICE. AS PER RECEIVED CONDITION OF DEVICE; THE INVESTIGATION SHOWS THAT THE TIP OF THE SCREWDRIVER IS TWISTED AND IS PARTIALLY FISSURED. 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. BASED ON THE RECEIVED INFORMATION THE EXACT ROOT CAUSE CANNOT BE DETERMINED. THE HEX TIP WAS PREVIOUSLY IN A WORN CONDITION, NORMAL WEAR AND TEAR OVER THE YEARS, AND BY THIS SITUATION AN EXCESSIVE SCREWING FORCE WAS NECESSARY WHICH FINALLY COULD LEAD TO THE COMPLAINED ISSUE. BECAUSE OF THE DAMAGE, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY OF THE VALID MANUFACTURING SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED. THEREFORE, THIS MANUFACTURING EVALUATION IS TO BE INVALID FROM A MANUFACTURING STANDPOINT. 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 DURING AN INVENTORY REVIEW THE FOLLOWING INSTRUMENTS WERE NOT FUNCTIONING PROPERLY: THE CANNULATED 4.0MM HEXAGONAL SCREWDRIVER HAD A CRACK FROM THE TIP TO THE SHAFT. THE STAR-DRIVE SCREWDRIVER T25, SELF-RETAINING, HAS AN END THAT IS TWISTED AND IT WON¿T HOLD TIGHT ONTO SCREWS. THE STAR-DRIVE SCREWDRIVER, T25 AND THE STAR-DRIVE SCREWDRIVER T15 BOTH HAVE TWISTED TIPS. THERE WERE NO REPORTED ADVERSE EVENTS DUE TO THE INSTRUMENT ISSUES OR REPORTED PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291820 CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SCREWDRIVERS HXX SYNTHES HAGENDORF 3277443

    Patients

    Seq Age Sex Outcome Treatment
    1