BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT TIP T25 DRIVER-LONG

    MDR report key: 3072431 · Received April 23, 2013

    Report

    Report Number
    8030965-2013-11039
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    July 9, 2012
    Report Date
    July 9, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PRODUCT DEVELOPMENT EVALUATION REVEALED THAT APPROXIMATELY 4-5MM OF THE DISTAL TIP ON BOTH RETURNED SCREWDRIVER SHAFTS HAVE SHEARED OFF. THE FAILURE PATTERN ON BOTH RETURNED DEVICES SHOWS A DISTINCT COUNTER-CLOCKWISE HELICAL SHEAR PATH CONSISTENT WITH THE APPLICATION OF EXCESSIVE LOOSENING TORQUES. DESIGN EVALUATION REVEALED THAT THE TIPS OF THE DEVICES WERE DESIGNED TO OPTIMIZE THE TORSIONAL STRENGTH FOR A NON-RETAINING DRIVER. THE PROFILE WAS BASED ON A SYNTHES STANDARD FOR (B)(4), EXCEPT IT HAS ADDITIONAL MATERIAL BETWEEN THE LOBES FOR ADDED STRENGTH. THE DESIGN OF THE MATING RECESS ENABLES THIS OPTIMIZATION. IN ORDER TO ENSURE NON-RETENTION, THE TIP PROFILE IS CONSTANT FOR THE LENGTH OF PENETRATION INTO THE MATING RECESS. (B)(4). IN ORDER TO CAUSE A T25 DRIVER TO FRACTURE, TORQUES IN EXCESS OF (B)(4) MUST HAVE BEEN APPLIED. SINCE THIS IS IMPOSSIBLE TO ACHIEVE WITH A MATRIX 10 NM TORQUE-LIMITING HANDLE, THE DAMAGED DEVICES MUST HAVE BEEN UTILIZED IN A MANNER INCONSISTENT WITH THE RECOMMENDED TECHNIQUE. THEREFORE, THE COMPLAINT IS INVALID FROM A DESIGN PERSPECTIVE.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS THE SURGEON WAS TIGHTENING PEDICLE SCREW FOR POST L2-S1 FUSION, TWO DRIVERS TIPS BROKE. THERE ARE NO PIECES TO RETRIEVE AND THE SURGERY WAS COMPLETED WITH ANOTHER DRIVER. NO ADVERSE EVENT TO THE PATIENT. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174281 STRAIGHT TIP T25 DRIVER-LONG HXX SYNTHES GMBH 7614373

    Patients

    Seq Age Sex Outcome Treatment
    1