BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLEEV 2PART L50 F/MEF

    MDR report key: 8104295 · Received November 26, 2018

    Report

    Report Number
    8030965-2018-58481
    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

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL NARRATIVE: DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART: 392.927, LOT: L639583. MANUFACTURING LOCATION: HÄGENDORF, 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 EXECUTION WAS CARRIED OUT WITH JAMMING PROBLEMS. THEREFORE, THE DIMENSIONAL INSPECTION TOOK PLACE, ACCORDING TO THE VALID INSPECTION SHEETS AT THAT TIME. THE DIMENSIONAL INSPECTION PASSED SUCCESSFUL ALL TESTS. THEREFORE IT IS ASSUMED, THAT THE PART 392.941 ¿SPLINED-SHAFT-THREAD F/SEGM-TRANSP L300¿ WITH LOT NUMBER L639530 ALONE IS THE REASON FOR THE JAMMING ISSUE. 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

    REPORTER IS SYNTHES SALES CONSULTANT. (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 7 OF 7 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943007 SLEEV 2PART L50 F/MEF GUIDE FZX OBERDORF SYNTHES PRODUKTIONS GMBH L639583 07611819088856

    Patients

    Seq Age Sex Outcome Treatment
    1