BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 70MM

    MDR report key: 4778224 · Received May 18, 2015

    Report

    Report Number
    2520274-2015-13904
    Event Type
    Injury
    Date Received
    May 18, 2015
    Report Date
    April 20, 2015
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    KTT
    PMA / PMN Number
    PK023941
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 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 AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE MANUFACTURING LOCATION: BETTLACH FOR ALL LOTS. FOR ALL LOTS: 413.370S 9210182, MANUFACTURING DATE: 28.OCT.2014, EXPIRY DATE: 01.OCT.2024. 413.365S 9179438, MANUFACTURING DATE: 13.OCT.2014, EXPIRY DATE: 01.OCT.2024. 413.350S 9211353, MANUFACTURING DATE: 30.OCT.2014, EXPIRY DATE: 01.OCT.2024. 413.336S 8858298, MANUFACTURING DATE: 11.MAR.2014, EXPIRY DATE: 01.MAR.2024. 413.338S 8916856, MANUFACTURING DATE: 08.APR.2014, EXPIRY DATE: 01.APR.2024. 413.342S 8969842, MANUFACTURING DATE: 19.MAY.2014, EXPIRY DATE: 01.MAY.2024. 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. 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

    MANUFACTURING INVESTIGATION EVALUATION: THE RETURNED SCREWS WERE VISUALLY REVIEWED AND DETERMINED TO ALL BE INTACT. NO PRODUCT FAILURE WAS DETECTED. THIS REPORTED PLATE BROKE AT AN OCCUPIED SCREW HOLE. THIS REPORT IS FOR THE SCREW THAT OCCUPIED THAT PLATE-HOLE. EIGHT INTACT SCREWS WERE RECEIVED. IT IS UNKNOWN WHICH OF THE RETURNED SCREWS OCCUPIED THE PLATE-HOLE. POTENTIAL PART/LOT COMBINATIONS ARE AS FOLLOWS: 413.370S / 9210182: 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 70MM / KTT - APPLIANCE, FIXATION, NAIL / K023941. 413.365S / 9179438: 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 65MM / KTT - APPLIANCE, FIXATION, NAIL / K023941. 413.350S / 9211353: 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 50MM / KTT - APPLIANCE, FIXATION, NAIL / K023941. 413.336S / 8858298: 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 36MM / KTT - APPLIANCE, FIXATION, NAIL / K000682. 413.338S / 8916856: 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 38MM / KTT - APPLIANCE, FIXATION, NAIL / K000682. 413.342S / 8969842: 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 42MM / KTT - APPLIANCE, FIXATION, NAIL / K000682. (B)(4). 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 PATIENT INITIALLY UNDERWENT A HIGH TIBIAL OSTEOTOMY PROCEDURE ON (B)(6) 2015 DURING WHICH A TOMOFIX ((B)(4)) PLATE WAS IMPLANTED. ON AN UNKNOWN DATE, THE PLATE BROKE. THE PATIENT PRESENTED WITH PAIN AT THE END OF (B)(6) 2015, WHEN AN X-RAY CONFIRMED DEVICE BREAKAGE AT A SCREW HOLE. THE PLATE HAS BROKEN AT AN OCCUPIED SCREW HOLE. ACCORDING TO THE SURGEON, THE PLATE MAY HAVE BEEN PLACED A LITTLE TOO FAR FORWARD THAN THE DESIRED POSITION. NO EXCESSIVE LOADS WERE APPLIED TO THE EFFECTED PART WITH THE EXCEPTION OF REHABILITATION. A REVISION PROCEDURE TOOK PLACE ON (B)(6) 2015 WITH ANOTHER COMPANY¿S PLATE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321794 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 70MM APPLIANCE,FIXATION,NAIL KTT SYNTHES BETTLACH 9210182

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention