BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER FOR DETACHABLE TEMPORARY FIXATION PIN

    MDR report key: 3062473 · Received April 16, 2013

    Report

    Report Number
    1719045-2013-10694
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    December 7, 2011
    Report Date
    December 7, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED FOR A MANUFACTURING EVALUATION AND WAS MANUFACTURED BY BEERE PRECISION (PRESENTLY TELEFLEX MEDICAL). DUE TO AN UNKNOWN CAUSE, ONE OF THE FLANGES ON THE TIP OF THE DRIVER WAS BROKEN OFF AND ANOTHER FLANGE WAS SLIGHTLY BENT. THE PART EXHIBITED MINOR SCRATCHES NEAR THE TIP AND ALONG THE SHAFT. THE EVALUATION INDICATED THAT THE REPORTED FAILURE IS NOT ASSOCIATED WITH THE MANUFACTURING PROCESSES AT TELEFLEX MEDICAL. THEREFORE, BASED ON THE EVALUATION AND THE UNKNOWN ROOT CAUSE, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING STANDPOINT. A PRODUCT DEVELOPMENT EVALUATION WAS ALSO PERFORMED. ONE OF THE SIX FLANGES ON THE TIP OF THE DRIVER THAT SPLAYS TO RETAIN THE DETACHABLE TEMP FIXATION PIN WAS MISSING. IT APPEARED TO HAVE FRACTURED AT THE SMALLEST CROSS SECTION BETWEEN THE HOLES IN THE SLOTTED CUTS THAT FORM THE FLANGES. BASED ON THE REMAINING MATERIAL AT THE FRACTURE SITE, IT APPEARED TO HAVE BEEN BENT OUT AND AWAY FROM THE DRIVER AXIS AT THE TIME OF FRACTURE. AN ADJACENT FLANGE WAS PLASTICALLY DEFORMED AND SLIGHTLY BENT OUT AND AWAY FROM THE DRIVER AXIS AS WELL. THE REMAINDER OF THE INSTRUMENT HAD MINOR SCRATCHES ALONG THE SHAFT AND AT THE METAL END OF THE HANDLE. THE DESIGN OF THE TEMPORARY FIXATION PIN DRIVER FOR THE ANTERIOR TENSION BAND SYSTEM WAS EVALUATED AND FOUND TO BE APPROPRIATE FOR ITS INTENDED APPLICATION. THE FLANGES ON THE TIP OF THE TEMP FIXATION PIN DRIVER ARE INTENDED TO SPLAY OVER THE DETACHABLE TEMPORARY FIXATION PIN HEAD AND RETAIN IT ON THE DRIVER ONCE THE HEX DRIVE IS ENGAGED. PROPER ENGAGEMENT AND SPLAYING OF THE FLANGES OCCURS WHEN THE AXES OF THE TEMP FIXATION PIN AND DRIVER ARE ALIGNED WHEN BEING ASSEMBLED. PLASTIC DEFORMATION OR FAILURE OF THE FLANGES MAY OCCUR IF EXCESSIVE FORCES ARE APPLIED OFF THE DRIVER AXIS. TWO TEMPORARY FIXATION PIN DRIVERS ARE ALSO PROVIDED IN THE SET. THE FRACTURE OF THE DRIVER TIP FLANGES WAS MOST LIKELY A RESULT OF MISUSE, CAUSING EXCESSIVE OFF-AXIS LOADING TO THE INSTRUMENT. HOWEVER, NOT ENOUGH INFORMATION WAS PROVIDED IN THE COMPLAINT TO DETERMINE THAT THIS IS THE EXACT ROOT CAUSE. THEREFORE, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A DESIGN STANDPOINT.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANTERIOR LUMBAR INTERBODY FUSION PROCEDURE AT LEVELS L5-S1, ONE OF THE FLANGES ON THE PIN HOLDER THAT HOLDS THE TIP OF THE PIN BROKE OFF. IT DID NOT BREAK INTO THE WOUND AND THERE WAS NOTHING TO RETRIEVE. THE SURGEON USED ANOTHER PIN HOLDER TO COMPLETE THE PROCEDURE. THIS REPORT IS FOR FILE (B)(4).

    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
    162151 DRIVER FOR DETACHABLE TEMPORARY FIXATION PIN LXH SYNTHES MONUMENT 559463M05

    Patients

    Seq Age Sex Outcome Treatment
    1