BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOSITPC 60 9X30MM

    MDR report key: 8491428 · Received April 8, 2019

    Report

    Report Number
    3004549189-2019-00014
    Event Type
    Malfunction
    Date Received
    April 8, 2019
    Date of Event
    April 14, 2015
    Report Date
    March 18, 2019
    Manufacturer
    S.B.M. SAS
    Product Code
    MAI
    PMA / PMN Number
    K122228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    FOR REGULARIZATION - RETROSPECTIVE REVIEW / FDA REQUEST. THESE TWO BATCHES OF SCREWS PRESENT NO MANUFACTURING DEFECTS. EVERYTHING CONFORMS TO SPECIFICATIONS. BASED ON THE MANUFACTURING PROCESS RECORDS FOR THESE BATCHES OF COMPOSITCP SCREWS, THE SOURCE OF THE DEFECT CANNOT BE ATTRIBUTED TO THE MANUFACTURING CONDITIONS. OBSERVATION OF THE SCREWS REVEALS A RUPTURE WHICH COMBINES BOTH TORSIONAL STRESS AND PERFORATION AT THE BEGINNING OF THE SCREW RECESSES. GIVEN THE ELEMENTS PROVIDED REGARDING THE CIRCUMSTANCES SURROUNDING THESE RUPTURES AND BASED ON THE OBSERVATIONS OF THE SCREWS RETURNED TO SBM, THE FOLLOWING CONCLUSION WAS DRAWN: BECAUSE THE DIAMETER OF THE TUNNEL WAS TOO SMALL AND THE PIN WAS NOT PROPERLY ORIENTED DUE TO ITS FLEXIBILITY, THE ENTRY CONE OF THE SCREW WAS JAMMED AGAINST THE CORTICAL BONE. THE TIP OF THE SCREW WAS ONLY WEAKLY DRIVEN BY THE SCREWDRIVER IN THIS AREA AND WAS SUBJECTED TO TORSIONAL STRESS AT THE JUNCTION POINT WHERE THE GUIDE PIN GUIDING ARE MEETS THE SCREW RECESS. THE TIP OF THE SCREW BEING JAMMED, THE TORSIONAL STRESS WAS GREATER THAN THE YIELD POINT OF DUOSORB, WHICH CAUSED THE SCREW TO RUPTURE.

    Description of Event or Problem · 1

    FNC (B)(4) - FOR REGULARIZATION - RETROSPECTIVE REVIEW / FDA REQUEST. IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, THE TIP OF TWO SCREWS FRACTURED WHEN THE SURGEON WAS SCREWING THE IMPLANT INTO THE TUNNEL. ANOTHER BIOMET 9X25MM SCREW WAS USED TO COMPLETE THE PROCEDURE WITH NO DELAY. ALL PIECES WERE RETRIEVED FROM THE PATIENT. SURGEON MENTIONED THAT HE DID NOT USE TOO MUCH FORCE WITH THE SCREWDRIVER. 1ST SCREW : LOT 142583 - MANUFACTURING DATE : AUG. 25TH 2014 - EXPIRATION DATE : AUG. 25TH 2017. 2ND SCREW : LOT 142979 - MANUFACTURING DATE : SEPT. 27TH 2014 - EXPIRATION DATE : SEPT. 27TH 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283740 COMPOSITPC 60 9X30MM INTERFERENCE SCREW MAI S.B.M. SAS 142583 + 142979

    Patients

    Seq Age Sex Outcome Treatment
    1 Other