BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLEEV 2PART L50 F/MEF

    MDR report key: 8104269 · Received November 26, 2018

    Report

    Report Number
    8030965-2018-58480
    Event Type
    Malfunction
    Date Received
    November 26, 2018
    Report Date
    November 7, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    FZX
    UDI-DI
    07611819088856
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART: 392.927, LOT: L639583. MANUFACTURING LOCATION: (B)(4), RELEASE TO WAREHOUSE DATE: NOV 06, 2017. THE DEVICE HISTORY RECORD SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND FUNCTIONAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. 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. 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 392.927 ¿SLEEV 2PART L50 F/MEF¿ IS IN GOOD CONDITION. SOME NORMAL GRINDING TRACES ON THE INSIDE OF USING THE INSTRUMENT CAN BE SEEN. THIS INDICATES NORMAL WEAR AND TEAR NO DAMAGE OR SIGNIFICANT MARKS ON SURFACE COULD BE IDENTIFIED. THE REVIEW OF THE DEVICE HISTORY RECORD REVEALED THAT THIS SLEEVE WAS MANUFACTURED IN NOV 2017 ACCORDING TO THE SPECIFICATIONS. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS WITH NO NON-CONFORMITIES REPORTED. SINCE IT IS POSSIBLE TO REPRODUCE THE DESCRIBED COMPLAINT WITH ALL PARTS SHIPPED BACK, A FUNCTIONAL TEST WAS CARRIED OUT IN ACCORDANCE TO TECHNIQUE GUIDE. THE TEST WAS EXECUTED WITHOUT ANY JAMMING PROBLEMS. THE MECHANISM OF THE FIRST SLEEVE 392.927 ¿SLEEV 2PART L50 F/MEF¿ WITH LOT NUMBER L639583, WORKS WITHOUT ANY ISSUES. 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 392.927. 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

    (510K): DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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) SLEEVE. THIS IS REPORT 6 OF 7 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942570 SLEEV 2PART L50 F/MEF GUIDE FZX OBERDORF SYNTHES PRODUKTIONS GMBH L639583 07611819088856

    Patients

    Seq Age Sex Outcome Treatment
    1