BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUTTRESS/COMPR-NUT F/PFNA BLADE

    MDR report key: 3834390 · Received May 28, 2014

    Report

    Report Number
    9612488-2014-10197
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 26, 2014
    Report Date
    April 28, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HST
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE 510K#: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION WAS PERFORMED. THE BUTTRESS NUT IS COMPLETELY STUCK ON THE SLEEVE AND CAN NOT BE REMOVED. SYNTHES (B)(4) MANUFACTURED 356.817 LOT NO 2588958. THE PARTS WERE MADE TO (B)(4) REV 'A'. 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. THE RELEVANT DIMENSIONS OF THE BUTTRESS NUT CAN NOT BE VERIFIED DUE TO THE DAMAGE INCURRED. THERE ARE HEAVY MARKS AND SCRATCHES VISIBLE. THE BUTTRESS NUT IS JAMMED ON THE SLEEVE. THEREFORE THIS COMPLAINT IS JUDGED TO BE INDETERMINATE FROM A MANUFACTURING STANDPOINT. 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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 WHEN THE SURGEON ATTEMPTED TO LOCK THE PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) BLADE THE SCREWDRIVER COULD NOT BE SEPARATED FROM THE BLADE. IT WAS REPORTED TO BE IMPOSSIBLE TO MOVE THE SCREWDRIVER AND EVERYTHING WAS BLOCKED, EVEN THE TROCAR. A HAMMER WAS USED TO REMOVE THE TROCAR AND THE PFNA BLADE WHICH WAS BLOCKED IN THE PATIENT. THE NAIL AND BLADE WERE REMOVED AND REPLACED WITH A NAIL FROM ANOTHER COMPANY THIS IS REPORT 4 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312759 BUTTRESS/COMPR-NUT F/PFNA BLADE TRACTION, APPARATUS, NON-POWERED HST SYNTHES BETTLACH 2588958

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR