BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSION/DISTRACTION INSTRUMENT

    MDR report key: 10465519 · Received August 28, 2020

    Report

    Report Number
    8030965-2020-06418
    Event Type
    Malfunction
    Date Received
    August 28, 2020
    Report Date
    August 4, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWN
    UDI-DI
    07611819375819
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    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 INVESTIGATION SUMMARY: COMPLAINT IS CONFIRMED AS WE ARE ABLE TO CONFIRM COMPLAINT DESCRIPTION (MISSING PART) BASED ON THE RECEIVED PICTURES. VISUAL INSPECTION: UPON VISUAL INSPECTION OF THE COMPLAINT DEVICE IT CAN BE SEEN THAT WE HAVEN¿T RECEIVED ALL PARTS OF THE CONSTRUCT, AS MENTIONED FROM CUSTOMER (PICTURE ATTACHED TO PC LEVEL), PICTURES FROM RECEIVED CONDITION AND PARTS ATTACHED TO PI LEVEL. IN ADDITION, IT¿S VISIBLE THAT THE MENTIONED PART IS MISSING AS REPORTED, THIS THUS CONFIRMING THE COMPLAINT DESCRIPTION. OTHERWISE, THE RECEIVED PARTS IN A GOOD CONDITION. FURTHERMORE, THERE ARE NO SIGNS OF A FOREIGN SUBSTANCE. DOCUMENT/SPECIFICATION REVIEW: DRAWINGS AND REVISIONS ARE IN ACCORDANCE TO DHR OF PRODUCTION LOT T173844. ALL RELEVANT FEATURES ARE DEFINED ON THE USED DRAWING REVISIONS OF DHR OF PRODUCTION LOT T173844. SUMMARY: THE REVIEW OF THE PRODUCTION HISTORY REVEALED THAT THIS ITEM WAS MANUFACTURED IN FEBRUARY 2019 ACCORDING TO THE SPECIFICATIONS. NO MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT CONDITION WERE FOUND. MOREOVER, A REVIEW OF OUR COMPLAINTS DATA BASE SHOWS, THAT THERE ARE NO OTHER COMPLAINTS FOR THIS ISSUE FROM THIS ARTICLE AND LOT NUMBER. THE CAUSE OF COMPLAINED MALFUNCTION IS A POST-MANUFACTURING CAUSED AND/OR USE RELATED, THEREFORE THE IN THE INVESTIGATION FLOW LISTED REMAINING INVESTIGATION STEPS ARE NOT REQUIRED. AS REPORTED THE PART GOT LOST BY REPROCESSING. TO PREVENT SUCH PROBLEMS, IT IS NECESSARY TO OPERATE ACCORDING TO THE DISASSEMBLY ASSEMBLY INSTRUCTION. 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. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY: PART NUMBER: 03.111.021. LOT NUMBER: T173844. MANUFACTURING SITE: TUTTLINGEN. RELEASE TO WAREHOUSE DATE: 06-FEB-2019. A REVIEW OF THE DEVICE HISTORY RECORDS 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

    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 · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED A COMPRESSION INSTRUMENT IS MISSING A COMPONENT. THE "WING NUT" HAS GONE MISSING DURING WASH. THE REST OF THE DEVICE IS UNDAMAGED. IT WAS FURTHER NOTED THE DEVICE SEEMS CONTAMINATED WITH FOREIGN MATERIAL. NO PATIENT OR PROCEDURE INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929284 COMPRESSION/DISTRACTION INSTRUMENT INSTRUMENT COMPRESSION HWN OBERDORF SYNTHES PRODUKTIONS GMBH T173844 07611819375819

    Patients

    Seq Age Sex Outcome Treatment
    1