BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIM-ARM 130° F/PFNA BLADE

    MDR report key: 4240791 · Received November 10, 2014

    Report

    Report Number
    9612488-2014-10495
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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 NO PRODUCT WAS RECEIVED. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: AIMING ARM RETURNED FOR EVALUATION INTACT BUT IN USED CONDITION. THE PROVIDED FUNCTIONAL TEST SHOWED NO ANOMALIES TO THE FUNCTION; THE NUT COULD BE SCREWED ON TO THE PROTECTION SLEEVE. THE SLEEVE ASSEMBLY COULD BE CLICKED INTO THE AIMING ARM AND WAS LOCKING AS REQUIRED. THE AIMING ARE WAS MANUFACTURED, MEETING ALL SPECIFICATIONS. THE ARTICLE WAS MANUFACTURED ACCORDING TO OUR PRODUCTION DOCUMENTS. 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 THE SURGEON COULD NOT APPLY THE COMPRESSION NUT IN QUESTION PROPERLY AT FIRST. THEN HE MANUALLY HELD THE SLEEVE AND INSERTED A GUIDE WIRE SO THAT HE COULD INSERTED THE BLADE, BUT WITHOUT SUCCESS. AS HE CONFIRMED THE BLADE WAS AT THE RIGHT POSITION THROUGH X-RAY, HE ATTEMPTED TO EXTRACT THE BLADE WITH DIFFICULTY. FINALLY AFTER HE EXTRACTED THE BLADE IN QUESTION, HE INSERTED SAME BLADE WITHOUT ANY PROBLEM AND COMPLETED THE SURGERY. THE SURGERY WAS EXTENDED FOR 30 MINUTES DUE TO THIS EVENT. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722087 AIM-ARM 130° F/PFNA BLADE GUIDE FZX SYNTHES BETTLACH 8938219

    Patients

    Seq Age Sex Outcome Treatment
    1