BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTER-LOCK SCREWDRIVER T25/3.5MM HEX/330MM

    MDR report key: 3021541 · Received March 26, 2013

    Report

    Report Number
    8030965-2013-10580
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    April 27, 2012
    Report Date
    April 27, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4). OPERATOR OF DEVICE WAS A HEALTH PROFESSIONAL. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED AND THE TIP WAS STRIPPED WITH A FEW SMALL NICKS IN THE TIP OF THE SHAFT OF THE DRIVER. THE HARDNESS WAS CHECKED DURING THE MANUFACTURING EVALUATION AND WAS FOUND ACCORDING TO THE SPECIFICATION. HOWEVER, THE RELEVANT DIMENSIONS COULD NOT BE VERIFIED DUE TO DAMAGE. THE COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT. ACCORDING TO THE PRODUCT DEVELOPMENT EVALUATION, THE DEVICE DESIGN, MATERIAL, PACKAGING, AND TOLERANCE STACKS DID NOT APPEAR TO HAVE ATTRIBUTED TO THE COMPLAINT. SINCE THE DRIVER SLIPPED, IT IS POSSIBLE THAT THE DEVICE WAS NOT SEATED AND LOCKED PROPERLY IN THE SCREW RECESS. THE COMPLAINT COULD NOT BE REPLICATED. A METALLURGICAL EVALUATION WAS ALSO PERFORMED. HARDNESS TESTING DETERMINED THAT THE DEVICE MET REQUIREMENTS. THE COMPLAINT IS INVALID FROM A DESIGN STANDPOINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANTEGRADE FEMORAL NAIL PROCEDURE, THE SURGEON WAS SEATING THE SCREW WHEN THE INTER-LOCK SCREWDRIVER SLIPPED AND THE TIP CHIPPED. THE SCREWDRIVER WOULD NOT HOLD THE SCREW. THE SLIDING PORTION OF THE INTER-LOCK SCREWDRIVER WAS NOT SEATING THE SCREW AS IT SHOULD. THE SURGEON WAS ABLE TO SEAT THE SCREW DOWN WITH THE SCREWDRIVER. THE SURGEON THEN USED A STAR DRIVE SCREWDRIVER TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS. NO ADVERSE EFFECT TO THE PATIENT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124725 INTER-LOCK SCREWDRIVER T25/3.5MM HEX/330MM HXX SYNTHES GMBH 7843930

    Patients

    Seq Age Sex Outcome Treatment
    1