BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM CRTX SCREW/LOW PROF HD SELF-TAPPING/STAR DRIVE/44MM

    MDR report key: 4111149 · Received September 23, 2014

    Report

    Report Number
    1719045-2014-10463
    Event Type
    Injury
    Date Received
    September 23, 2014
    Report Date
    August 27, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    PK111230
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THE 3.5MM CORTEX SCREW WAS RETURNED BROKEN WHERE THE SCREW HEAD TRANSITIONS TO THE SHAFT. THE LOT AND PART NUMBER ARE READABLE. THE SCREW HEAD RECESS WAS SLIGHTLY DEFORMED. SIX 2.7MM VA LOCKING SCREWS, ONE 3.5MM VA LOCKING SCREW, AND ONE 3.5MM LOW PROFILE CORTEX SCREW WERE RETURNED FOR REPORTEDLY BREAKING POST-OPERATIVELY. IT WAS TAKEN INTO ACCOUNT THAT 2 OF THE SCREW HEADS RETURNED BELONGED TO 2 OF THE 2.7MM VA SCREWS. THERE WERE 4 SCREWS THAT BROKE WHERE THE HEAD TRANSITIONS TO THE BODY AND SO A DETERMINATION AS TO WHICH SCREWS THE HEADS BELONGED TO COULD NOT BE MADE. THE LEFT 2.7MM/3.5MM VA LOCKING COMPRESSION PLATE (LCP) MEDIAL DISTAL TIBIA PLATE WAS NOT RETURNED FOR EVALUATION AS THE PATIENT WANTED TO KEEP IT. THE 2.7MM/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM TECHNIQUE GUIDE WAS REVIEWED. NOTES ARE INCLUDED TO HIGHLIGHT IMPORTANT STEPS SUCH AS ENSURING REDUCTION AND COMPRESSION IS COMPLETED BEFORE INSERTING LOCKING SCREWS, USING A MINIMUM OF FIVE 2.7MM VA LOCKING SCREWS IN THE PLATE HEAD HOLES, AND ENSURING THAT THE PLATE AND SCREW POSITIONING DOES NOT RESTRICT MOTION AT THE ANKLE JOINT. THE RELEVANT PRODUCT DRAWINGS WERE REVIEWED DURING THE INVESTIGATION. ALTHOUGH THE MANUFACTURING DATE IS UNKNOWN, THE LATEST DRAWINGS WERE REVIEWED BECAUSE THE SCREWS ARE NOT MULTI-USE DEVICES AND SO WERE LIKELY MANUFACTURED RECENTLY TO THE CURRENT DRAWING REVISIONS. ALL OF THE SCREWS ARE MADE USING IMPLANT QUALITY STAINLESS STEEL PER ES0362 (SEC CONDITION ONLY FOR THE 3.5MM VA LOCKING SCREW) AND IS ADEQUATE FOR THEIR INTENDED USE. MECHANICAL TEST HAS SHOWN THE VA LCP MEDIAL DISTAL TIBIA PLATES HAVE ADEQUATE FATIGUE STRENGTH TO MAINTAIN REDUCTION AND FIXATION OF DIAPHYSEAL AND METAPHYSEAL FRACTURES OF THE DISTAL TIBIA. ADDITIONALLY, THE VA 2.7MM SCREWS ARE BENEFICIAL TO THE CONSTRUCT BECAUSE THEY HAVE THE ABILITY TO CAPTURE COMMINUTED FRAGMENTS. THE DESIGN IS DEEMED ADEQUATE AND LIKELY DID NOT CONTRIBUTE TO THE COMPLAINT CONDITION. THE BROKEN SCREWS MAY HAVE RESULTED FROM POOR SCREW PLACEMENT, NOT ENOUGH SCREWS IN THE PLATE HEAD HOLES, OR PATIENT NON-COMPLIANCE HOWEVER THE EXACT ROOT CAUSE CANNOT BE DETERMINED. REVIEW OF THE DRAWINGS AND MECHANICAL TESTING FOUND THE IMPLANTS ADEQUATE FOR THEIR INTENDED USE. 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

    A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT NO NCRS 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.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

    IT WAS REPORTED THAT A PATIENT CAME IN FOR REMOVAL OF BROKEN HARDWARE (DATE OF ORIGINAL IMPLANT: ESTIMATED (B)(6) 2013). THE BONE DID NOT HEAL FAST ENOUGH, REPORTED AS "NON-UNION." ON (B)(6) 2014, THE PATIENT UNDERWENT EXPLANT, A BONE GRAFT, AND PLACEMENT OF NEW HARDWARE. THE REMOVAL OF THE BROKEN HARDWARE WAS DIFFICULT AND REQUIRED ADDITIONAL INTERVENTION WHICH EXTENDED THE OPERATIVE TIME TO EQUAL OR GREATER THAN 30 MINUTES. THE BROKEN SCREWS WERE SOME 2.7 VA LOCKING SCREWS, 3.5 VA LOCKING SCREWS, AND A 3.5 LOW PROFILE CORTEX SCREW. INFORMATION ON THE SCREW SIZES IS UNKNOWN, AS THEY ARE BROKEN AND SOME OF THEM ARE JUST THE HEADS OF THE SCREWS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT'S OUTCOME IS UNKNOWN. THIS REPORT IS 4 OF 4 OF (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591422 3.5MM CRTX SCREW/LOW PROF HD SELF-TAPPING/STAR DRIVE/44MM SCREW, FIXATION, BONE HWC SYNTHES MONUMENT 7037664

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention