BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOLT Ø4.9 SELF-TAP L38 TAV GREEN

    MDR report key: 2923114 · Received January 18, 2013

    Report

    Report Number
    8030965-2013-00180
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Report Date
    December 20, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO A DEVICE MARKETED IN THE UNITED STATES. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) REPORTED THE FOLLOWING FROM A FACILITY IN (B)(6): PATIENT IMPLANTED WITH A PROXIMAL FEMORAL NAIL ANTIROTATION II ON 11/11/2011 FOR DISLOCATION OF THE DISTAL END OF THE CLAVICLE. PATIENT REPORTEDLY FELL RESULTING IN THE TRAUMA OF THE CLAVICLE. ON (B)(6) 2011, PATIENT LEFT HOSPITAL WITH A TRIANGULAR BANDAGE. ON (B)(6) 2011, SUTURES WERE REMOVED AND SURGEON CHECKED THE AFFECTED PART. X-RAYS SHOWED NO ISSUES. (B)(6) 2011, PATIENT RETURNED TO HOSPITAL COMPLAINING OF PAIN AT THE AFFECTED PART. SURGEON NOTED BONE FRACTURE AT THE PROXIMAL END OF THE PLATE. THE PLATE WAS NOT BROKEN. THE RE-FRACTURE OCCURRED BEFORE REHABILITATION. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2012 TO REMOVE THE BROKEN NAIL. THE SURGEON COULD NOT FIND ANY PROBLEM WITH HAT HOOK POSITION AND THE POSTOPERATIVE PROGRESS HAS BEEN GOING WELL. BUT HE FOUND THE BREAKING PART OF THE PFNA II ON THE X-RAY IMAGES ON (B)(6) 2012. THERE IS NO PROBLEM WITH THAT HOOK POSITION. THIS IS # 4 OF 4 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28467 BOLT Ø4.9 SELF-TAP L38 TAV GREEN BOLT HTN SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR NAIL, BLADE, BOLT