BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4416485 · Received January 14, 2015

    Report

    Report Number
    2520274-2015-10333
    Event Type
    Injury
    Date Received
    January 14, 2015
    Report Date
    October 15, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR A SCREW, PART AND LOT NUMBERS UNKNOWN. HOWEVER, OF THE TEN RECEIVED SCREWS, TWO HAVE BEEN IDENTIFIED: PART 204.830 LOT 8850569 AND PART 204.842 LOT 8852639. BOTH OF THE TWO IDENTIFIED SCREWS COME FROM LOTS THAT WERE MANUFACTURED AT SYNTHES (B)(4). HOWEVER, IT IS NOT KNOWN IF ONE OF THESE SCREWS WAS IMPLANTED IN THE HOLE AT WHICH THE PLATE BROKE. BOTH OF THE TWO IDENTIFIED SCREWS COME FROM LOTS THAT WERE MANUFACTURED ON FEBRUARY 13, 2014. HOWEVER, IT IS NOT KNOWN IF ONE OF THESE SCREWS WAS IMPLANTED IN THE HOLE AT WHICH THE PLATE BROKE. OF THE TWO SCREWS THAT HAVE BEEN IDENTIFIED, NO NONCONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. 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

    THE SUBJECT SCREWS WERE RECEIVED BUT NOT EVALUATED AS IT IS UNKNOWN WHICH SCREW WAS PRESENT AT THE SCREW HOLE WHERE THE PLATE FRACTURE OCCURRED. THE SCREWS WERE RECEIVED IN AN INTACT CONDITION AND THE EVALUATION OF THE ASSOCIATE PLATE WAS REPORTED IN MEDWATCH REPORT FOLLOW-UP 3 FOR (B)(4). 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

    AN IMAGE READING WAS PERFORMED BY A MEDICAL DIRECTOR AT DEPUY SYNTHES. HE STATED ¿I CAN CONFIRM THE BREAKAGE OF THE DISTAL TIBIA PLATE.¿

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(6) REPORTS THE FOLLOWING: ON (B)(6) 2014, THE PATIENT WAS TREATED WITH AN UNSPECIFIED COMPETITOR¿S EXTERNAL FIXATION FOR A GUSTILO 2 OPEN FRACTURE. ON (B)(6) 2014, THE EXTERNAL FIXATION WAS REMOVED DUE TO POOR REDUCTION AND REVISED TO A TIBIAL NAIL AND FIBULAR PLATE. ON (B)(6) 2014, DISPLACEMENT OF THE FRACTURE WAS TREATED WITH DISTAL TIBIA VARIABLE ANGLE LOCKING CONDYLAR PLATE. ON (B)(6) 2014, BREAKAGE OF THE PLATE WAS NOTED; THE PATIENT ¿HAD A CASTER AND WALKED ON IT¿ (SIC). ON (B)(6) THE PATIENT WAS REVISED TO A TIBIAL NAIL. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4). THIS REPORT IS FOR THE SCREW THAT WAS IMPLANTED IN THE HOLE AT WHICH THE PLATE BROKE THAT WAS NOTED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33405 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention