BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER BIHEX Ø3 W/T-HANDLE

    MDR report key: 3183759 · Received June 23, 2013

    Report

    Report Number
    8030965-2013-03830
    Event Type
    Malfunction
    Date Received
    June 23, 2013
    Report Date
    January 19, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ACTUAL EVENT DATE NOT KNOWN. THE DEVICES WERE RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. THE INVESTIGATION OF THE TWO COMPLAINED SCREWDRIVERS HAS SHOWN THAT THE TIPS ARE BROKEN OFF COMPLETELY. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED. CONCLUSION: THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE AS NO PRODUCT FAULT COULD BE DETECTED. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS REPORTED PROBLEM. WHILE WE DO PRESUME THOUGH, THAT TOO MUCH APPLIED MECHANICAL FORCE DURING THE PROCEDURE CAUSED THIS DAMAGE, WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE AND THE COMPLAINT CONDITION REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF TWO DOUBLE-HEX SCREWDRIVERS WITH T-HANDLES BROKE OFF WHEN SCREWING IN THE LOCKING CAP DURING FINAL TIGHTENING. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284621 SCREWDRIVER BIHEX Ø3 W/T-HANDLE HXX SYNTHES GMBH 1873399

    Patients

    Seq Age Sex Outcome Treatment
    1