BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT TIP T25 DRIVER STANDARD

    MDR report key: 2954735 · Received February 11, 2013

    Report

    Report Number
    8030965-2013-00381
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    January 14, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVALUATION WAS CONDUCTED. THE DRIVER WAS RECEIVED WITH A FRACTURED TIP WITH TWISTING BELOW THE FRACTURE. THE FRACTURED TIP WAS NOT RETURNED. THE TWISTING AT THE TIP IS INDICATIVE THAT THE DRIVER FAILED WHILE IT WAS TURNING COUNTERCLOCKWISE. THIS MEANS THAT IT POSSIBLY FAILED DURING A LOOSENING OF A SCREW AND NOT DURING FINAL TIGHTENING AS DESCRIBED IN THE COMPLAINT. THERE IS ALSO NO MENTION OF THE TORQUE-LIMITING HANDLE BEING USED. IF THE TORQUE-LIMITING HANDLE WAS NOT USED, THERE IS NO WAY OF DETERMINING WHAT TORQUE WAS USED. THE APPEARANCE OF THE FRACTURED TIP ON THE RETURNED ITEM MATCHES THE APPEARANCE OF DRIVERS THAT WERE TESTED IN A LABORATORY SETTING AT SYNTHES. IN THE LABORATORY TEST, YIELDING OCCURRED AT APPROXIMATELY 15NM, AND SHEARING OCCURRED AT GREATER THAN OR EQUAL TO 20NM. THIS SUGGESTS THAT THE RETURNED PART WAS SUBJECTED TO TORQUE AS HIGH AS 20NM. AS THE FAILURE MODE (TWISTING ORIENTATION) DOES NOT MATCH THE FINAL TIGHTENING CLOCK WISE MOTION AND IT IS NOT KNOWN WHETHER OR NOT THE REQUIRED TORQUE-LIMITING HANDLE WAS USED A CONCLUSION CANNOT BE DETERMINED, FROM A DESIGN PERSPECTIVE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DEVICE WAS EXAMINED: TIP IS BROKEN OFF AND WAS NOT SENT BACK FOR INVESTIGATION. THE REMAINDER OF THE T25 TIP IS BADLY TWISTED IN COUNTER-CLOCKWISE DIRECTION. THE DEVICE HISTORY RECORDS SHOW THAT THE CORRECT MATERIAL, X15TN, WAS USED AND THAT THE HARDNESS WAS ACCORDING TO THE SPECIFICATION, 59.5 HRC. THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY AS WELL. IT IS CLEARLY VISIBLE THAT THE SCREWDRIVER WAS BADLY TWISTED BEFORE IT BROKE, THIS IS A CLEAR INDICATION THAT FAR TOO MUCH TORQUE WAS APPLIED ONTO THIS DEVICE TO LOOSE PAR EXAMPLE, A BLOCKED LOCKING CAP. HOWEVER, THE RELEVANT DIMENSIONS CAN NOT BE VERIFIED ANYMORE BECAUSE OF THE DAMAGE AND BECAUSE THE BROKEN FRAGMENT WAS NOT SENT BACK FOR INVESTIGATION. THEREFORE, THE COMPLAINT DESCRIPTION DOES NOT MATCH WITH THE APPEARANCE OF THE DAMAGE, UNLESS THE SCREWDRIVER WAS NOT DAMAGED AND THEREFORE WEAKENED DURING A PREVIOUS PROCEDURE.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE TIP OF THE SCREWDRIVER BROKE OFF DURING FINAL TIGHTENING. THE CASE WAS FINISHED WITHOUT FURTHER INCIDENT AND NO PIECES WERE LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59416 STRAIGHT TIP T25 DRIVER STANDARD SCREWDRIVER HXX SYNTHES GMBH 7662568

    Patients

    Seq Age Sex Outcome Treatment
    1