BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM

    MDR report key: 3971272 · Received July 31, 2014

    Report

    Report Number
    3000270450-2014-10059
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HRS
    PMA / PMN Number
    PK100776
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PRODUCT INVESTIGATION: THE 02.118.406 2.7MM VARIABLE ANGLE LCP (VA-LCP) LATERAL DISTAL FIBULA PLATE IS USED IN THE 2.7MM/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM. THE LATERAL DISTAL FIBULA PLATES ARE INTENDED FOR FIXATION OF OSTEOTOMIES, FRACTURES, NONUNIONS, MALUNIONS, AND REPLANTATIONS OF BONES AND BONE FRAGMENTS OF THE DIAPHYSEAL AND METAPHYSEAL REGIONS OF THE DISTAL FIBULA. IT WAS REPORTED THAT THE VARIABLE ANGLE (VA) LOCKING SCREWS WOULD NOT LOCK INTO THE PLATE. BOTH THE PLATE AND THE SCREWS WERE RETURNED. WHEN THE PARTS WERE ASSEMBLED, THE RETURNED SCREWS WOULD NOT LOCK INTO THE PLATE; THUS THE COMPLAINT IS CONFIRMED. HOWEVER, THERE IS SIGNIFICANT DAMAGE TO THE THREADS ON THE HEAD OF THE SCREWS AND IN THE LOCKING PORTION OF VARIABLE ANGLE HOLES IN THE PLATE. IT IS THIS DAMAGE THAT IS PREVENTING THE SCREWS FROM LOCKING INTO THE PLATE. THIS TYPE OF DAMAGE IS CONSISTENT WITH SCREWS BEING OVER TORQUED DUE TO A TORQUE LIMITING ATTACHMENT (TLA) NOT BEING USED DURING INSERTION. EVEN WHEN INSERTING THE SCREWS BY HAND, USING THE TLA IS NECESSARY TO PREVENT DAMAGE TO THE THREADS. THE TECHNIQUE GUIDE FOR THE DISTAL FIBULA VA-LCP PLATES STATES THAT: ¿USE OF THE TORQUE LIMITER IS MANDATORY WHEN ENGAGING THE SCREWS INTO VARIABLE ANGLE LOCKING HOLES TO ENSURE THE APPROPRIATE AMOUNT OF TORQUE IS APPLIED.¿ DRAWINGS WERE REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED USE OF THE PARTS. AFTER REVIEWING THE RELATED PRODUCT DRAWINGS AND COMPLAINT HISTORY, THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. AS THE SCREWS COULD NOT BE LOCKED INTO THE PLATE, THE COMPLAINT IS CONFIRMED. HOWEVER, THE MALFUNCTION WAS CAUSED BY DAMAGED THREADS, WHICH IN TURN ARE LIKELY DUE THE SCREWS BEING INSERTED WITHOUT A TLA. BECAUSE THE COMPLAINT CONDITION IS THE RESULT OF METHOD OF USE AND NOT A DESIGN DEFICIENCY THE DEVICE IS DETERMINED TO BE SUITABLE FOR ITS INTENDED USE. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: HWC. DEVICE WAS NOT IMPLANTED/EXPLANTED. NON-STERILE PART 02.211.016 LOT. 7639880 DEVICE HISTORY RECORDS WERE REVIEWED: NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. STERILE PART: 02.211.016S LOT. 8947206: THE PRODUCT WAS STERILIZED BY A THIRD PARTY VENDOR ((B)(4)) IN EUROPE. NO COMPLAINT RELATED ISSUES WERE REPORTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION WAS COMPLETED: THE HEAD THREADS ARE DAMAGED AND DEFORMED. THERE ARE NICKS ON SHAFT THREAD. THE STARDRIVE IS FEATURE IS DAMAGE AND DEFORMED. THE OVERALL LENGTH WAS CHECKED AND NO ISSUES FOUND. THE SHAFT THREAD PROFILE WAS CHECKED IN A SECTION WITHOUT NICKS AND FOUND ACCEPTABLE. THE STARDRIVE SIZE, STARDRIVE TAPER DEPTH, STARDRIVE STRAIGHT DEPTH, HEAD PROFILE AND HEAD THREAD PROFILE COULD NOT BE CHECKED DUE TO DAMAGE. SINCE ALL RELEVANT FEATURES COULD NOT BE CHECKED THIS COMPLAINT CANNOT BE CONFIRMED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SCREWS DID NOT ENGAGE AND LOCK INTO THE THREADS OF TWO OF THE VARIABLE ANGLE HOLES ON THE PLATE. WHEN USING THE ABOVE MENTIONED PLATE, TWO OF THE DISTAL LOCKING HOLES WERE PREDRILLED USING A 2MM DRILL AND VARIABLE ANGLE 2.7 DRILL GUIDE USING THE FIXED ANGLE. WHEN INSERTING THE 2.7 VARIABLE ANGLE LOCKING SCREWS, THEY DID NOT ENGAGE AND LOCK INTO THE THREADS OF THE VARIABLE ANGLE HOLES, THEY CONTINUED TO ROTATE. THE SURGEON WAS NOT HAPPY WITH THE OVERALL FIXATION OF THE PLATE, SO HE REMOVED IT AND REPLACED WITH OUR LOCKING COMPRESSION PLATE LATERAL DISTAL FIBULA PLATE. ONCE THE PLATE AND THE SCREWS WERE DECONTAMINATED THE SCREWS WERE STILL UNABLE TO BE LOCKED INTO THE HOLES. THERE WAS ABOUT A TWENTY TO TWENTY-FIVE MINUTE DELAY IN THE PROCEDURE; THERE WAS NO PATIENT HARM. THIS IS REPORT 4 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446892 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM PLATE, FIXATION, BONE HRS SYNTHES SELZACH 8947206

    Patients

    Seq Age Sex Outcome Treatment
    1