BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLEEV 2PART L50 F/MEF

    MDR report key: 7960873 · Received October 12, 2018

    Report

    Report Number
    8030965-2018-57255
    Event Type
    Malfunction
    Date Received
    October 12, 2018
    Date of Event
    September 14, 2018
    Report Date
    September 26, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    LXH
    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 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 · 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. PART 392.927, LOT L042606: MANUFACTURING SITE: HÄGENDORF. RELEASE TO WAREHOUSE DATE: AUGUST 17, 2016. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF DEVICES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS COMPLETED: THE DEVICES WERE RECEIVED IN AN ASSEMBLED CONDITION. ALL DEVICES ARE IN A USED CONDITION WITH SEVERAL MECHANICAL DAMAGES ON ITS SURFACES. FURTHERMORE, THE THREAD AT THE SPLINED-SHAFT-THREAD (392.941) WAS FOUND BADLY DAMAGED. THE RETURNED DEVICES WERE DISMANTLED AND CHECKED FOR ITS FUNCTIONALITY. BESIDES THE SPLINED-SHAFT-THREAD (392.941) THE DEVICES WERE FULLY FUNCTIONAL AS PER DESIGN INTENDED. THE THREAD ON THE SPLINED-SHAFT-THREAD (392.941) DEVICE IS DEFORMED IN A MANNER WHICH PREVENTS ACCURATE FUNCTIONAL CHECK. OUR INVESTIGATION HAS SHOWN THAT THE COMPLAINT CONDITION CANNOT BE REPLICATED, BUT DUE TO THE DAMAGES AT THE SPLINED-SHAFT-THREAD (392.941) THIS COMPLAINT WILL BE RATED AS CONFIRMED AS THE FUNCTIONALITY ON THIS DEVICE IS NOT GIVEN ANYMORE. ALL DAMAGES ARE CLEARLY CAUSED POST MANUFACTURING. UNFORTUNATELY, WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS COMPLAINT. DUE TO THE VARIOUS DAMAGES, IT IS LIKELY THAT ALL RECEIVED DEVICES WERE OFTEN AND INTENSIVE USED. WE ALSO CONSIDER THAT THE SPLINED-SHAFT-THREAD (392.941) ENCOUNTERED UNINTENDED FORCES (SUCH AS BEING DROPPED OR HEAVY STROKE ISSUES DURING ITS USE) WHICH COULD HAVE FINALLY LEAD TO THE COMPLAINED ISSUE. FOR SUCH CASES THE SURGICAL TECHNIQUE'S GUIDE RECOMMENDS AS FOLLOWS: VISUAL INSPECTION FOR WEAR OF THE FIXATION PARTS AFTER EVERY USE IS ESSENTIAL. IN PARTICULAR, THE RILLS IN THE SADDLE JOINT AND SADDLE WASHER OF THE STANDARD CLAMPS MUST BE INSPECTED FOR WEAR. IF THERE ARE ANY VISIBLE SIGNS OF WEAR, THE COMPONENT IN QUESTION SHOULD NOT BE USED ANY LONGER. THE DECISION TO REUSE IT RESTS WITH THE SURGEON. THE PARTS OF THE STANDARD CLAMPS (EXCLUDING THE SCREWS), THE SLEEVES AND THE SPLINED SHAFT OF THE CENTRAL BODY CANNOT BE ORDERED AS SPARE PARTS. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. 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 · 0

    THE DEVICE WAS 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 · 0

    IT WAS FURTHER REPORTED THAT THE MALFUNCTIONS WERE DETECTED BEFORE USE AND HENCE THE PATIENT WAS NOT AFFECTED.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (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 INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 (B)(6) 2018 DURING AN UNKNOWN SURGERY, FIXING OF INSTRUMENT WAS DIFFICULT BECAUSE SCREWS COULD NOT BE FIXED PROPERLY AND WERE STUCK. IT WAS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND IF THERE WAS A SURGICAL DELAY. THERE WAS NO PATIENT OUTCOME REPORTED. THIS REPORT IS FOR ONE (1) SLEEV 2PART L50 F/MEF. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800843 SLEEV 2PART L50 F/MEF MISC ORTHO SURGICAL INSTR LXH OBERDORF SYNTHES PRODUKTIONS GMBH L042606 07611819088856

    Patients

    Seq Age Sex Outcome Treatment
    1