BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURELOCK AIMING ARM FOR ANTEGRADE FEMORAL NAILS

    MDR report key: 3021479 · Received March 26, 2013

    Report

    Report Number
    8030965-2013-10593
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    October 31, 2011
    Report Date
    October 31, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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 SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. MANUFACTURING EVALUATION REVEALED THAT THE RETURNED ADJUSTING SCREW AND MOVABLE GUIDING WERE RECEIVED BLOCKED. THE ADJUSTING SCREW GOT BLOCKED ON THE MOVABLE GUIDING BLOCK DUE TO INADEQUATE USE. THE MOVABLE GUIDING BLOCK WAS IN A MISALIGNED POSITION WHILE THE ADJUSTING SCREW WAS SCREWED DOWN. THIS COMPLAINT IS DEEMED INVALID FROM A MANUFACTURING STANDPOINT. PRODUCT DEVELOPMENT EVENT EVALUATION REVEALED THAT THE RETURNED DEVICE DID NOT HAVE ANY UNUSUAL SIGNS OF WEAR. THE THREADED BOLT AT THE PIVOT POINT OF THE AIMING ARM WAS ASSEMBLED INCORRECTLY. THE AIMING ARM WAS DISASSEMBLED FROM ITS ORIGINAL STATE AND RE-ASSEMBLED INCORRECTLY AFTER MANUFACTURING BY THE USER, CENTRAL PROCESSING, OTHER HOSPITAL/OR STAFF, OR THE SALES CONSULTANT. SPECIFICALLY, THE THREADED BOLT AT THE PIVOT POINT OF THE AIMING ARM WAS ASSEMBLED INCORRECTLY. DURING THE EVALUATION, THE THREADED BOLT WAS REMOVED AND RE-ASSEMBLED IN THE PROPER LOCATION, AT WHICH POINT THE AIMING ARM FUNCTIONED NORMALLY. THE THREADED BOLT OF THE AIMING ARM IS NOT MEANT TO BE DISASSEMBLED FOR CLEANING. ADDITIONALLY, PICTURES IN THE TECHNIQUE GUIDE PROVIDE EVIDENCE OF THE APPROPRIATE ORIENTATION OF THE THREADED BOLT. BECAUSE THE DEVICE WAS DISASSEMBLED UNNECESSARILY AND REASSEMBLED INCORRECTLY, THIS COMPLAINT IS INVALID.

    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 (B)(4) 2011. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT HIP TFN PROCEDURE, THE SURGEON WENT TO USE THE SURELOCK AIMING ARM AND IT WOULD NOT LOCK DOWN. SURGEON DID NOT SELECT ANOTHER AIMING ARM, BUT RATHER DRILLED FREE HAND. THERE WERE NO PROBLEMS DRILLING FREEHAND AND THE PROCEDURE WAS COMPLETED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124490 SURELOCK AIMING ARM FOR ANTEGRADE FEMORAL NAILS FZX SYNTHES GMBH 2331685

    Patients

    Seq Age Sex Outcome Treatment
    1