BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIM-ARM 130° F/PFNA BLADE

    MDR report key: 3813139 · Received May 15, 2014

    Report

    Report Number
    9612488-2014-10172
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 21, 2014
    Report Date
    May 5, 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

    ADDITIONAL NARRATIVE: ADDITIONAL PRODUCT CODE: HWC. 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 DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. NO NON-CONFORMANCE 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. 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

    LASER ETCHING IS READABLE, COLOR MARKING EXISTS. THE INVESTIGATIONS FROM THE WORK ORDER SHOW NO DEVIATION AGAINST THE STANDARD WORKFLOW. TEST SUMMARY FROM THE FUNCTION FOLLOWS: 1. TEST FROM THE FUNCTION PART NUMBER 03.010.407 DID NOT SHOW DEVIATIONS. PART NUMBER 03.010.407 WAS MANUFACTURED ACCORDING TO THE DRAWING. THE RETURNED INSTRUMENTS WERE CHECKED FOR CONFORMANCE TO THE SPECIFICATIONS AND FOR FUNCTIONING; NEITHER A PRODUCT NOR A FUNCTION FAULT COULD BE DETECTED. THE PRESENT INSTRUMENTS MEET ALL MEASURABLE DIMENSIONS AND WERE FOUND TO BE IN PERFECT WORKING ORDER. FURTHER INVESTIGATION REGARDING MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT NUMBERS IN QUESTION. IN ADDITION THESE INSTRUMENTS ARE FUNCTION CHECKED PER 100% BEFORE THEY LEAVE THE MANUFACTURING FACILITY. 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 AIMING ARM SLEEVE FOR GUIDE WIRE SEEMS TO BE BENT OR TWISTED. THE LOCKING SLIDING INSERT DOES NOT HOLD THE SLEEVE; IT CAN FALL OUT OF THE LOCKING MECHANISM. THERE WAS NO PATIENT HARM. THERE WAS DELAY OF THE PROCEDURE FOR A MAXIMUM OF TWO MINUTES. THIS IS REPORT 1 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290452 AIM-ARM 130° F/PFNA BLADE GUIDE FZX SYNTHES BETTLACH 2618470

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR