BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STD-CLAMP F/MEF

    MDR report key: 8104201 · Received November 26, 2018

    Report

    Report Number
    8030965-2018-58477
    Event Type
    Malfunction
    Date Received
    November 26, 2018
    Report Date
    November 7, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    LXH
    UDI-DI
    07611819083721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT INVESTIGATION WAS COMPLETED. SEVERAL PARTS OF A MEFISTO® EXTERNAL FIXATION SYSTEM WERE RETURNED FOR INVESTIGATION AS THE PARTS WERE FOUND TO BE JAMMING. INSTRUMENTS WERE CHECKED FOR CONFORMANCE TO THE SPECIFICATIONS. THE SHIPPED BACK INSTRUMENT 392.903 STANDARD CLAMP F/MEFISTO® IS IN A GOOD CONDITION. NO DAMAGE OR SIGNIFICANT MARKS ON SURFACE COULD BE IDENTIFIED. DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED DUE TO MISSING LOT INFORMATION. FUNCTIONAL TEST DID NOT SHOW ANY ABNORMALITIES, MECHANISM WORKED WELL IN INTERACTION WITH THE RELATED INSTRUMENTS. THE RETURNED PART 392.903 ¿STD-CLAMP F/MEF¿ HAS NO DIRECT CONNECTION TO THE JAMMING OF PART# 392.941 AND 329.927, HENCE NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. THE INVESTIGATION CONFIRMED, THAT THE COMPLAINT CONDITION ¿ INABILITY TO ASSEMBLE - IS RELATED TO PART# 392.941. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED FOR PART 392.903. 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

    REPORTER IS SYNTHES SALES CONSULTANT. (510K): DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE DEVICE HAS BEEN RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON UNKNOWN DATE, DURING INCOMING GOODS INSPECTION, IT WAS IDENTIFIED THAT ONE (1) SPLINED SHAFT, ONE (1) SLEEVE FOR SEGMENT TRANSPORT, ONE (1) STANDARD CLAMP, ONE (1) BASE PLATE FOR T-ASSEMBLY, ONE (1) ANGLED PIECE FOR T-ASSEMBLY AND TWO (2) SLEEVES DID NOT FIT PROPERLY. FUNCTIONAL ISSUE WAS IN ASSEMBLED STATE. PARTS WERE NOT MOVEABLE AND WERE JAMMING. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) STANDARD CLAMP. THIS IS REPORT 3 OF 7 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941440 STD-CLAMP F/MEF MISC ORTHO SURGICAL INSTR LXH OBERDORF SYNTHES PRODUKTIONS GMBH 07611819083721

    Patients

    Seq Age Sex Outcome Treatment
    1