BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM TI CORTEX SCREW SLF-TPNGWITH T8 STARDRIVE RECESS 26MM

    MDR report key: 3192352 · Received June 27, 2013

    Report

    Report Number
    2520274-2013-03821
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K063049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PER PRODUCT DEVELOPMENT EVENT EVALUATION, THE RETURNED TORQUE LIMITING ATTACHMENT 1.2NM (PART 03.110.002, LOT 4739) WAS MANUFACTURED IN FEBRUARY 2011 AND IS OVER 2 YEARS OLD. THE DEVICE WAS RETURNED IN 4 SEPARATE PIECES (HOUSING, NOSE PIECE, SPRING AND COLLAR). THE SHAFT SHEARED IN HALF AT THE DISTAL TIP. THE REMAINDER OF THE SHAFT (THREADED PORTION) IS STUCK IN THE THREAD OF THE HOUSING AND CANNOT BE REMOVED WITHOUT DESTROYING IT AND THE FEATURES OF INTEREST RELEVANT TO THIS COMPLAINT. THE FRACTURE FACE OF THE THREAD REMAINDER IS ANGLED (APPROXIMATELY 45 DEGREES) AND IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY. THE FRACTURE IS INDICATIVE OF TOO MUCH TORSIONAL FORCE OR TOO MUCH OFF-AXIS LATERAL STRESS. THE DEVICE IS DESIGNED TO INSERT LOCKING COMPRESSION SCREWS AT A TORQUE OF 1.2 NM ±0.12 TO ALLOW PRECISE LOCKING OF THE SCREW HEAD THREAD TO THE PLATE HOLE THREAD. THE 2.4X 2.7MM VARIABLE ANGLE LCP FOREFOOT MIDFOOT SYSTEM RISK ANALYSIS ADEQUATELY ADDRESSES THIS COMPLAINT CONDITION. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THE RETURNED 2.4 X 2.7MM TI VA LOCKING X-PLATE SMALL (PART 04.211.202, LOT 3749939) WAS WITH PLATE HOLE THREAD OBSERVED WORN BUT NOT BROKEN AS COMPLAINED. THE 2.4 X 2.7MM VARIABLE ANGLE LCP FOREFOOT MIDFOOT SYSTEM RISK ANALYSIS ADEQUATELY ADDRESSES THIS COMPLAINT CONDITION. THREE RETURNED 2.7 X 26MM TI VA LOCKING SCREW (PART 04.211.026) AND ONE 2.7 X 28MM TI VA LOCKING SCREW (PART 04.211.028) SHOW WEAR AND MARKS IN THE ANODIZE LAYER. THE SCREWS ARE NOT BROKEN AS COMPLAINED. THE SCREWS ARE DESIGNED TO LOCK INTO THE PLATE THREAD ONCE A TORQUE OF 1.2NM IS ACHIEVED. THE DAMAGE TO THE SCREWS AND PLATE ARE DUE TO OVER TORQUING OF THE SCREWS (SIGNIFICANTLY IN EXCESS OF 1.2NM) AS THE TORQUE LIMITING ATTACHMENT WAS BROKE AND NOT AVAILABLE FOR USE. THREE CORTEX SCREWS (2.7 X 26MM TI CORTEX SCREW (PART 402.886), 2.7 X 34MM TI CORTEX SCREW (PART 402.894), 2.7 X 36MM TI CORTEX SCREW (PART 402.896) WERE RECEIVED WITH SCREW THREADS WORN BUT NOT DAMAGED. THE DAMAGE TO THE SCREWS AND PLATE ARE DUE TO OVER TORQUING OF THE SCREWS (SIGNIFICANTLY IN EXCESS OF 1.2NM) AS THE TORQUE LIMITING ATTACHMENT WAS BROKE AND NOT AVAILABLE FOR USE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION WAS PERFORMED AND THE REPORT INDICATES THE THREAD FLANKS OF THE SCREW ARE COMPLETELY STRIPPED. THERE ARE MARKS OF FORCIBLE USE AT THE STARDRIVE RECESS AND STRESS MARKS AT THE BOTTOM OF THE SCREW HEAD VISIBLE. THE RELEVANT DIMENSIONS OF THE SCREW CAN NOT BE VERIFIED DUE TO THE DAMAGE AT THE THREAD. AT ALL DAMAGES THE ANODIZATION LAYER IS WORN OUT, WHICH INDICATES THAT THE DAMAGES WERE CAUSED POST-MANUFACTURING EITHER DURING INSERTION OR EXTRACTION, LIKELY BY AN EXCESSIVE CONTACT WITH THE PLATE. THE STRESS MARKS AT THE BOTTOM INDICATE THAT THE SCREW HEAD WAS IN CONTACT WITH THE PLATE AFTER INSERTION AS REQUIRED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). CONTACT NAME CHANGED TO (B)(6), CHU MANAGER. 510K NUMBER UPDATED.

    Description of Event or Problem · 1

    A PATIENT, IMPLANTED DURING A CALCANEAL PROCEDURE ON (B)(6) 2013, RETURNED TO SURGEON COMPLAINING OF PAIN. FOLLOW-UP X-RAYS SHOWED INCREASED DISPLACEMENT OF THE CALCANEAL BONE. DURING THE REVISION SURGERY WHILE SURGEON WAS IMPLANTING THE TOP RIGHT LOCKING SCREW INTO THE VA LOCKING X PLATE, THE LOCKING SCREW WENT THRU THE PLATE. ALSO, WHILE IMPLANTING THE LOCKING SCREW INTO THE BOTTOM LEFT SCREW HOLE OF THE X-PLATE THE SCREW WOULD NOT LOCK. THE SURGEON HAD NO ISSUES WITH IMPLANTING THE TOP LEFT AND BOTTOM RIGHT SCREWS. SURGEON THEN REMOVED THE TOP RIGHT AND THE TOP LEFT SCREWS AND REPLACED THEM WITH CORTICAL SCREWS. SURGEON DID NOT LIKE THE POSITION OF THE SCREWS AND PLATE. HE NOTED ON X-RAY THAT THE SCREWS WERE IN A PROMINENT POSITION ABOVE THE PLATE AND SCREWS DID NOT SIT FLUSH WITH THE PLATE. SURGEON REMOVED THE 2 SCREWS AND DETERMINED THAT THE HOLES IN THE BONE WERE NOW TOO BIG FOR HIM TO REINSERT 2.4MM LOCKING SCREWS. AGAIN SURGEON TOOK X-RAYS AND DETERMINED THAT THE VA X-PLATE AND SCREW CONSTRUCT WAS NOT HELPING THE PATIENT. SURGEON REMOVED THE VA X-PLATE AND SCREW CONSTRUCT AND REVISED PATIENT TO 2 4.5MM CORTEX SCREWS AND 2 13.0MM WASHERS. ALSO, WHILE THE SURGEON WAS USING THE 1.2MM TORQUE LIMITING ATTACHMENT TO INSERT THE CORTEX SCREW INTO THE TOP LEFT SCREW POSITION THE INSTRUMENT FELL APART. THE SPRING SHOT ACROSS THE ROOM AND THE TWO OTHER PIECES OF THE INSTRUMENT WERE FOUND IN THE STERILE FIELD. SURGEON CHOSE ANOTHER SCREWDRIVER TO COMPLETE THE SURGERY. DUE TO THESE EVENTS AN ADDITIONAL 1 HOUR AND 45 MINUTES WERE ADDED TO SURGERY TIME. THIS REPORT IS 6 OF 10 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292491 2.7MM TI CORTEX SCREW SLF-TPNGWITH T8 STARDRIVE RECESS 26MM HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention