BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI USS LOW PROFILE FRACTURE CLAMP

    MDR report key: 9087413 · Received September 19, 2019

    Report

    Report Number
    8030965-2019-68445
    Event Type
    Malfunction
    Date Received
    September 19, 2019
    Date of Event
    August 21, 2019
    Report Date
    August 21, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    NKB
    UDI-DI
    07611819182288
    PMA / PMN Number
    K082572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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, H6 INVESTIGATION SUMMARY: THE RETURNED FRACT-CLAMP WAS FORWARDED TO THE MANUFACTURING SIDE FOR EVALUATION. THE STATEMENT BELOW IS A SUMMARY OF THEIR INVESTIGATION. THE 2 RETURNED ITEMS HAVE BEEN RECEIVED NOT IN ORIGINAL PACKAGING. INFORMATION ETCHED MATCH TO COMPLAINT SYSTEM AND DEVICE HISTORY REVIEW (DHR). THE FIRST ITEM IS DISASSEMBLED IN ITS COMPONENTS (SEE THE REFERENCES ON THE ANALYSIS REPORT) AND SOME POST-PRODUCTION DAMAGE HAVE BEEN IDENTIFIED ON THE COMPONENT ART. 50132767 OF THE FIRST ITEM. THE SECOND ITEM IS STILL ASSEMBLED. NO EVIDENCE OF VISUAL NONCONFORMANCE MANUFACTURING RELATED. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION; THEREFORE, FURTHER CORRECTIVE AND/OR PREVENTIVE ACTION IS NOT REQUIRED. THE INVESTIGATION HAS SHOWN THAT THE CAUSE OF COMPLAINED MALFUNCTION IS A POST-MANUFACTURING CAUSED USE RELATED DAMAGE AT THE DEVICE. 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 HISTORY LOT. PART: 498.831S, LOT: 5L02181 (UNSTERILE 4L84575), MANUFACTURING SITE: SELZACH, SUPPLIER: FRUEH VERPACKUNGSTECHNIK AG, RELEASE TO WAREHOUSE DATE: 14. JUNE 2019, EXPIRY DATE: 01. JUNE 2029. DEVICE WAS FIRST MANUFACTURED UNSTERILE UNDER THE LOT: 4L84575 IN MEZZOVICO AND STERILIZED AFTERWARDS. AS THIS COMPLAINT IS NEITHER PACKAGING NOR STERILIZATION RELATED ONLY THE MANUFACTURING DOCUMENTS OF THE UNSTERILE DEVICE 498.831 WITH LOT: 4L84575 WERE REVIEWED: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER: 4L84575, 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

    ADDITIONAL PROCODES: KWP, KWQ, MNH, MNI. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, PATIENT UNDERWENT A SPINAL FUSION PROCEDURE TREATING L3 CRUSH FRACTURE. AT THE FINAL FIXATION STAGE WITH UNIVERSAL SPINE SYSTEM (USS) SCHANZ, THE SURGEON WAS NOT ABLE TO TIGHTEN THE NUT OF THE CLAMP. THEY COMPLETED THE FIXATION SUCCESSFULLY WITH A REPLACEMENT WITH LESS THAN A THIRTY (30) MINUTE DELAY. THE SURGEON COMMENTED THAT IT WAS NECESSARY TO REINSERT THE CLAMP AND A SCREW AS THE SCREW HAD BECOME LOOSE. BUT THEY HAPPENED TO TIGHTEN THE NUT EXCESSIVELY, WHICH RESULTED IN THOSE DEVICES TO BE BROKEN UP. SO, THE DEVICES WERE NEEDED TO BE REASSEMBLED. THIS REPORT IS FOR A TITANIUM (TI) USS LOW PROFILE FRACTURE CLAMP. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879735 TI USS LOW PROFILE FRACTURE CLAMP ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB OBERDORF SYNTHES PRODUKTIONS GMBH 5L02181 07611819182288

    Patients

    Seq Age Sex Outcome Treatment
    1