BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED 4.0MM HEXAGONAL SCREWDRIVER

    MDR report key: 3041718 · Received April 8, 2013

    Report

    Report Number
    8030965-2013-10802
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Report Date
    September 21, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 PRODUCT DEVELOPMENT EVALUATION REVEALED THAT THE INFORMATION CONTAINED IN THIS REPORT IS INSUFFICIENT TO DETERMINE THE CAUSE OF THE SCREWDRIVER TIP FAILURE. THE DESIGN INCLUDING CROSS SECTION ANALYSIS WAS REVIEWED AND DETERMINED TO MEET THE INTENDED USE. THE SCREWDRIVER TIP MIGHT HAVE BROKEN BECAUSE THE PATIENTS BONE WAS VERY HARD. IT IS RECOMMENDED TO PREDRILL PRIOR TO INSERTING SELF-DRILLING AND SELF-TAPPING SCREWS, REFER TO PAGE 10 OF 4.5MM LCP PROXIMAL FEMUR. THEREFORE, IT IS CONCLUDED THAT THIS COMPLAINT IS INDETERMINATE. THE MANUFACTURING EVALUATION SHOWED THAT TIP IS BROKEN OFF, FRAGMENTS WERE NOT SENT BACK. A MEASUREMENT OF THE BROKEN TIP IS NOT POSSIBLE AS THE FRAGMENTS WERE NOT SENT BACK. THEREFORE THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT. HOWEVER, THE STILL MEASURABLE DIMENSIONS ARE ACCORDING TO THE SPECIFICATION AND THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY.

    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. ORIGINAL AWARENESS DATE IS 9/21/11. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FEMORAL LOCKING PLATE PROCEDURE, THE TIPS OF TWO SCREWDRIVERS (314.050) BROKE OFF. THE FRAGMENTS WERE RETRIEVED FROM THE SCREW HEADS. IN THE SAME PROCEDURE, THE CABLE TENSIONER (391.201) WOULD NOT TIGHTEN THE CABLES. THE SURGEON USED ANOTHER TENSIONER IN THE SET TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEM. THIS IS REPORT 1 OF 3 FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144141 CANNULATED 4.0MM HEXAGONAL SCREWDRIVER HXX SYNTHES GMBH 3419440

    Patients

    Seq Age Sex Outcome Treatment
    1