BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 10MM

    MDR report key: 2891903 · Received December 31, 2012

    Report

    Report Number
    2520274-2012-04430
    Event Type
    Injury
    Date Received
    December 31, 2012
    Report Date
    December 4, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K000684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION IS FOR POSSIBLE SCREW RECEIVED. THIS SCREW APPEARS TO BE OF THE 212.101 FAMILY OF SCREWS. THE THREADED HEAD, 3.49 MM DIAMETER, AND LENGTH OF 10.66 MM SUGGEST THAT THIS MAY BE A 212.101. THE DRIVE IS LIGHTLY DAMAGED WITH SOME DISPLACED MATERIAL AT THE DRIVE ID. THE HEAD IS IN GOOD CONDITION. THERE IS SOME LIGHT COMPRESSION DAMAGE ON ONE SHAFT THREAD BUT DOES NOT AFFECT PROFILE. THE REMAINDER OF THE SCREW IS FREE OF ANY SIGNIFICANT DAMAGE. ALL OF THE PERTINENT DIMENSIONS THAT COULD BE CHECKED ARE WITHIN SPECIFICATIONS. BECAUSE NO LOT NUMBER WAS PROVIDED, A FINITE EVALUATION WAS NOT POSSIBLE. A REVIEW OF THE PLATE DESIGN INDICATED THAT THE YIELD STRENGTH OF THE PLATE WAS APPROPRIATE FOR THE INTENDED APPLICATION. THE COMPLAINT INDICATES THAT THE SURGEON WAS UNSURE IF THE PATIENT HAD FALLEN, SO THE SOURCE OF THE FAILURE IS NOT CLEAR. THE FAILURE MODE DESCRIBED IN THIS COMPLAINT IS IDENTIFIED IN THE RISK ANALYSIS FOR THIS PRODUCT AND IS ADEQUATE FOR THE INTENDED USE.

    Additional Manufacturer Narrative · 1

    (B)(4): SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.(B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH PLATE AND SCREW CONSTRUCT FOR AN ORIF OF A LEFT CLAVICLE, ON AN UNKNOWN DATE. ON AN UNKNOWN DATE, THE PLATE HAD BENT AND THE SCREWS PULLED OUT. SURGEON WAS UNSURE IF THIS MAY HAVE BEEN DUE TO A FALL. THE FRACTURE WAS ALSO A NON UNION. ON (B)(6) 2012, PATENT RETURNED TO THE OR AND THE HARDWARE WAS REMOVED AND REPLACED WITH NEW HARDWARE.THIS IS 4 OF 7 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 10MM LOCKING SCREW HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention PLATE, SCREWS