BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIM-ARM F/ETN RADIOLUC

    MDR report key: 10817806 · Received November 10, 2020

    Report

    Report Number
    8030965-2020-08818
    Event Type
    Malfunction
    Date Received
    November 10, 2020
    Date of Event
    October 9, 2020
    Report Date
    October 16, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    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. H3, H4, H6- THE RECEIVED AIMING ARM AND INSERTION HANDLE WERE RECEIVED IN A USED CONDITION. NO SIGNIFICANT DAMAGES COULD BE DETECTED, BESIDES OF SOME SCRATCHES. THE REPORTED CONDITION COULD BE CONFIRMED THAT THE CONNECTION SCREW OF THE AIMING ARM IS TOO SHORT AND CANNOT BE FIXED TO THE RETURNED INSERTION HANDLE. THE COMPLAINT CONDITION THAT THE CONNECTION SCREW IS TOO SHORT (MORE THEN 5MM) CAN BE CONFIRMED. NEVERTHELESS, WE ASSUME THAT THE CONNECTING SCREW WAS MISTAKENLY EXCHANGED WITH ANOTHER CONNECTING SCREW DURING THE CLEANING PROCESS OR USE. THE INSTRUMENTS UNDERWENT A 100% FUNCTIONAL CHECK BEFORE LEAVING THE PLANT. FURTHERMORE, THIS INSTRUMENT IS NOW OVER 8 YEARS IN USE, AND WE ASSUME THAT SUCH AN OBVIOUS FAILURE WOULD BE DETECTED ALREADY AT FIRST USE. BASED ON THE MEASUREMENTS, WE RATHER ASSUME THAT THE SCREW BELONGS TO THE AIMING ARM 03.010.018, WHICH IS ALSO USE WITH THE EXPERT TIBIA NAIL SET. CONSEQUENTLY, WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE HISTORY LOT PART NUMBER: 03.010.010, LOT NUMBER: 8073072, MANUFACTURING SITE: HAEGENDORF, RELEASE TO WAREHOUSE DATE: 06. DEC. 2012. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. PMA/510K: 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. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THAT THE CONNECTION SCREW FOR THE AIMING ARM WAS TOO SHORT AND THE THREAD ON THE AIMING ARM IS STRIPPED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH ANOTHER AIMING ARM AND THERE WAS NO SURGICAL DELAY REPORTED. THIS REPORT IS FOR ONE (1) AIMING ARM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1283366 AIM-ARM F/ETN RADIOLUC ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH 8073072

    Patients

    Seq Age Sex Outcome Treatment
    1