BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5MM TI CORTEX SCREW SELF-TAPPING 9MM

    MDR report key: 5161983 · Received October 20, 2015

    Report

    Report Number
    3000270450-2015-10214
    Event Type
    Injury
    Date Received
    October 20, 2015
    Date of Event
    October 7, 2015
    Report Date
    October 7, 2015
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HWC
    PMA / PMN Number
    PK112583
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: (B)(6). SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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 PRODUCT INVESTIGATION WAS COMPLETED: THE INVESTIGATION OF THE COMPLAINED SCREW SHOWS THAT THE SHAFT IS BROKEN APART DUE TO EXCESSIVE APPLIED MECHANICAL FORE WHILE INSERTION. MICROSCOPIC INVESTIGATION SHOWS THAT THE THREAD IS STRONGLY DAMAGED AS RESULT OF EXCESSIVE MECHANICAL FORCE DURING USE. DUE TO THE DAMAGES, IT IS NOT POSSIBLE TO MEASURE ANY DIMENSIONS. DEVICE HISTORY RECORD REVIEW STATES THAT THIS LOT WAS RELEASED AFTER CHECKING ALL RELEVANT DIMENSIONS DURING FINAL INSPECTION. NO MANUFACTURING RELATED ISSUE COULD BE IDENTIFIED. THEREFORE WE CLASSIFY THIS BREAKAGE AS RESULTED DUE TO MECHANICAL OVERLOADING DURING USE. NO INDICATION FOR MATERIAL, MANUFACTURING OR DESIGN RELATED ISSUE WAS FOUND. 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

    THE DEVICE BROKE INTRA-OPERATIVELY AND IS NOT CONSIDERED TO HAVE BEEN IMPLANTED OR EXPLANTED. THE COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(4) THE LARGER INCISION THAT WAS REQUIRED DUE TO THE FRAGMENTED SCREW. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. DEVICE HISTORY REVIEW (DHR): PLEASE NOTE, THIS DHR REVIEW IS FOR STERILIZATION PROCEDURE ONLY: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: AUGUST 19, 2014 - EXPIRY DATE: AUGUST 1, 2024. NO NON-CONFORMANCE REPORTS (NCR) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DHR SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NON-STERILE PART 400.809 / LOT 9000507: MANUFACTURING LOCATION: (B)(4); MANUFACTURING DATE: MAY 27, 2014. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DHR SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A CORTEX SCREW SHEARED AT ITS HEAD DURING A PROXIMAL PHALANGE FRACTURE PROCEDURE OF THE LEFT INDEX AND RING FINGERS. THE SHEARING OCCURRED AS THE SURGEON ATTEMPTED TO TIGHTEN THE CORTEX SCREW AFTER PLACING THE T-PLATE. THE SHAFT PORTION OF THE CORTEX SCREW REMAINED IN THE BONE, SO THE SURGEON MADE A SLIGHTLY BIGGER INCISION IN THE SURGICAL WOUND TO REMOVE THE BROKEN PIECE. THE OPERATION WAS PROLONGED FOR SIXTY (60) MINUTES. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693174 1.5MM TI CORTEX SCREW SELF-TAPPING 9MM SCREW, FIXATION, BONE HWC SYNTHES SELZACH 9106450

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention