BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5226481 · Received November 16, 2015

    Report

    Report Number
    2520274-2015-17285
    Event Type
    Malfunction
    Date Received
    November 16, 2015
    Date of Event
    October 7, 2015
    Report Date
    October 12, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    PK083213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. THIS REPORT IS FOR ONE (1) UNKNOWN SCREW WITH POSSIBLE PART NUMBERS AS FOLLOWS: PART 206.016: 4.0MM CANCELLOUS BONE SCREW FULLY THREADED/16MM ¿ HRS: PLATE, FIXATION, BONE / HWC: SCREW, FIXATION, BONE ¿ K083213. PART 206.024: 4.0MM CANCELLOUS BONE SCREW FULLY THREADED/24MM ¿ HRS: PLATE, FIXATION, BONE / HWC: SCREW, FIXATION, BONE ¿ K083213. ADDITIONAL PRODUCT CODES FOR THIS REPORT INCLUDE HWC. THE DEVICE BROKE INTRA-OPERATIVELY AND WAS NOT IMPLANTED OR EXPLANTED. PRODUCT INVESTIGATION SUMMARY: THE FOLLOWING DEVICE(S) WERE RECEIVED: 4.0MM CANCELLOUS SCREW (PART # 206.0XX / LOT # UNKNOWN) - QTY: 3, 4.0MM CANCELLOUS SCREW (PART # 206.024 / LOT # UNKNOWN) - QTY: 1, 4.0MM CANCELLOUS SCREW (PART # 206.018 / LOT # UNKNOWN) - QTY: 1. FIVE (5) IMPLANTS WERE RETURNED. TWO (2) SCREWS WERE INTACT AND UNDAMAGED. THE REMAINING THREE SCREWS WERE BROKEN WITH ONLY THE HEADS AND A SMALL PORTION (APPROXIMATELY 5MM) OF THE SHAFT RETURNED. THE NATURE OF THE DEFORMATION/BREAKAGE DID NOT ALLOW FOR AN ACCURATE IDENTIFICATION OF THE SCREW. THE CUTTING EDGES OF THE INTACT SCREWS ARE IN GOOD CONDITION. ALTHOUGH THE EXACT ROOT CAUSE IS UNKNOWN, IT IS LIKELY THAT THE BROKEN SCREWS WERE INSERTED INTO EXCESSIVELY HARD BONE WITHOUT PRE-DRILLING. A VISUAL INSPECTION AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS CONFIRMED. THE ASSOCIATED DRAWING FOR THE DEVICE(S) WAS REVIEWED. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. THE DESIGN IS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. PROPER USE AND MAINTENANCE FOR THE DEVICE(S) ARE ADDRESSED IN TECHNIQUE GUIDE. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED, IT DID NOT CONTRIBUTE TO THE COMPLAINT CONDITION. WITHOUT A VALID PART AND LOT NUMBER, A REVIEW OF THE DEVICE HISTORY RECORDS CANNOT BE REQUESTED. 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.

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT THE HEADS OF TWO (2) SCREWS POPPED OFF DURING THE INSERTION STAGE OF AN OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE ON (B)(6), 2015. UPDATED INFORMATION RECEIVED ON NOVEMBER 5, 2015, CONFIRMED THAT IT WAS IN FACT THREE (3) SCREW HEADS THAT SNAPPED DURING THE PROCEDURE. ALL OF THE SCREWS WERE REMOVED WITH NO FRAGMENTS RETAINED IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE OF BACK-UP SCREWS. A ONE (1) TO FIVE (5) DELAY WAS NOTED WITH A PATIENT POST-OPERATIVE STATUS OF "GOOD." THIS REPORT IS FOR ONE (1) UNKNOWN CORTEX SCREW. THIS REPORT IS 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754885 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1