BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM TI VA LCKNG SCR SLF-TPNGWITH T8 STARDRIVE RECESS 14MM

    MDR report key: 3052847 · Received April 11, 2013

    Report

    Report Number
    1719045-2013-00403
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Report Date
    February 6, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K100776
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. A REVIEW OF THE DESIGN INDICATES IT IS ACCEPTABLE FOR INSERTION AT AN ANGLE OF UP TO 15 DEGREES OFF THE NOMINAL AXIS, AS TESTED IN (B)(4). SYNTHES PROVIDES A DRILL GUIDE FOR THIS SPECIFIC PURPOSE. ONE OF THE SCREWS HAS SOME DAMAGE TO THE SHAFT, WHICH COULD HAPPEN IF THE SCREW IS INSERTED AT AN ANGLE GREATER THAN 15 DEGREES FROM NOMINAL, CAUSING THE SCREW SHAFT TO CONTACT THE PLATE. FURTHERMORE, WHEN INSERTED ON AXIS, THE SURGEON DID NOT HAVE A SIMILAR PROBLEM. THESE SCREWS ARE DESIGNED TO LOCK WHEN INSERTED AT UP TO 15 DEGREES OFF THE NOMINAL AXIS, AND INSTRUMENTATION IS PROVIDED TO AID IN THE INSERTION AND MITIGATE THE RISK OF OVER INSERTION. IT IS UNKNOWN IF THE SURGEON USED THE DRILL GUIDE WHEN INSERTING THE SCREW. THIS COMPLAINT IS DEEMED INVALID FROM A DESIGN PERSPECTIVE. PLACEHOLDER.

    Description of Event or Problem · 1

    DURING SURGERY FOR A 5TH METATARSAL OSTEOTOMY, AS THE SURGEON WAS PUTTING IN A VARIABLE ANGLE SCREW, THE SCREW HEAD DID NOT LOCK INTO THE PLATE AND CONTINUED TO SPIN. THE SCREW WAS REMOVED AND THE SURGEON TRIED ANOTHER SCREW WITH THE SAME RESULTS. THE SURGEON CHANGED THE ANGLE OF INSERTION WITH THE THIRD SCREW TO A NOMINAL ANGLE AND HAD NO PROBLEM LOCKING THE PLATE. THE ANGLE FOR THE INSERTION OF THE 1ST AND 2ND ATTEMPT IS UNKNOWN. SURGERY WAS PROLONGED APPROXIMATELY 2 MINUTES. NO ADVERSE EFFECT TO THE PATIENT WAS NOTED. THE SALES CONSULTANT THINKS THE BONE WAS SOFT WHICH ALLOWED THE SCREW TO GET OFF CENTER. THE SET IS BORROWED FROM THE METRO OFFICE AND A REPLACEMENT IS NOT NEEDED (ALREADY ORDERED). THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155901 2.7MM TI VA LCKNG SCR SLF-TPNGWITH T8 STARDRIVE RECESS 14MM HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male