BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA BLADE PERF L110 TAN

    MDR report key: 4250002 · Received November 14, 2014

    Report

    Report Number
    9612488-2014-10510
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 22, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A MANUFACTURING INVESTIGATION WAS CONDUCTED. THE REPORT INDICATES THAT THE INVESTIGATION OF THE COMPLAINED ARTICLES HAS SHOWN THAT THE BLADE IS STUCK INTO THE IMPACTOR. THE PARTS WERE REMOVED. IT WAS A LOT OF FORCE NECESSARY TO REMOVE THE BLADE FROM THE IMPACTOR. THE FOLLOWING FUNCTION TEST HAS SHOWN THAT ALL DEVICES ARE FUNCTIONAL AS REQUIRED. BASED ON THE PROVIDED COMPLAINT DESCRIPTION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE. THAT EITHER WRONG DIRECTION OF ROTATION OF THE LEFT-HAND THREADED MECHANISM OR THE USE OF THE KEY 356.823 CAUSED THE BLOCKING OF THE DEVICES. IN THIS RELATION WE WOULD LIKE TO POINT OUT THIS KEY SHOULD BE ONLY USED FOR THE REMOVAL OF THE BLADE. THE CONNECTION BETWEEN THE IMPACTOR AND THE PFNA BLADE WAS OVER TIGHTENED DURING FAILED INSERTION WHICH FINALLY LED TO THE JAMMING. 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

    ADDITIONAL PRODUCT CODE: HWC. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY THE BLADE COULD NOT BE REMOVED FROM THE INSERTER. THE PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) NAIL WAS REPLACED INTRAOPERATIVELY BECAUSE OF DAMAGES. THERE WAS A SURGICAL DELAY OF OVER 15 MINUTES REPORTED. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738722 PFNA BLADE PERF L110 TAN ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES BETTLACH 9110355

    Patients

    Seq Age Sex Outcome Treatment
    1