BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HN MULTILOC Ø7 IZQ CAN L255 TAN

    MDR report key: 9410628 · Received December 4, 2019

    Report

    Report Number
    8030965-2019-70729
    Event Type
    Injury
    Date Received
    December 4, 2019
    Date of Event
    November 7, 2019
    Report Date
    November 13, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819501201
    PMA / PMN Number
    K120807
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. PART: 04.017.255S, LOT: 4L05454, MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: MAY 24, 2019, EXPIRY DATE: MAY 01, 2024. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE VISUAL INVESTIGATION CONFIRMED THAT THE CONNECTION PART AT THE PROXIMAL END OF THE MULTILOC PROXIM HUMERAL NAIL IS DAMAGED. THE SHAFT IS IN GOOD CONDITION AND SHOWS BARELY SIGNS OF USE. DIMENSIONAL INSPECTION THE RELEVANT FEATURE IS DAMAGED IN A MANNER WHICH PREVENTS ACCURATE MEASUREMENT. DOCUMENT/SPECIFICATION REVIEW: 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. THE MATERIAL AND MATERIAL PROPERTIES OF THIS MULTILOC PROXIM HUMERAL NAIL WERE DETERMINED TO BE CONFORMING AT THE TIME OF MANUFACTURE. THIS NAIL IS MADE OF TITANIUM ALLOY (TAN) PER ISO (B)(4). FURTHERMORE, THESE NAILS ARE INSPECTED PER 100% BEFORE THEY LEAVE THE MANUFACTURING FACILITY. SUMMARY: THE MULTILOC PROXIM HUMERAL NAIL WAS EXAMINED AND THE COMPLAINT CONDITION IS CONFIRMED AS THE PROXIMAL PART OF THE MULTILOC PROXIM HUMERAL NAIL IS DAMAGED.. THIS PRODUCTION LOT WAS MANUFACTURED IN MAY 2019 ACCORDING TO THE SPECIFICATION. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS WITH NO NON-CONFORMITIES NOTED. THE DAMAGE OCCURRED IS DETERMINED TO BE POST PRODUCTION/ACCEPTANCE CRITERIAS. THE DEFORMATION OF THE PROXIMAL END OF THE MULTILOC PROXIM HUMERAL NAIL CLEARLY INDICATES THAT HIGH FORCES WERE APPLIED DURING USE. AS MENTIONED BY THE COMPLAINANT THE NAIL COULD NOT BE PROPERLY IMPLANTED AND HAD THEREFORE TO BE REMOVED BY USING A LOT OF FORCE. IN THIS REGARD, WE WOULD LIKE TO POINT OUT THAT FURTHER INFORMATION / PRECAUTION HINTS CAN BE FOUND IN THE RESPECTIVE SURGICAL TECHNIQUE. PLEASE NOTE, FOR IMPLANT REMOVAL THE EXTRACTION SCREW 03.019.024 SHOULD BE USED. THE INVESTIGATION FOUND NO MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT CONDITION. 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 · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW / INVESTIGATION, BUT HAS YET TO BE RECEIVED. 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. (B)(4). 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

    THE NAIL WAS ALMOST FULLY PLACED BUT JAMMED BEFORE PROPER PLACEMENT HAD OCCURRED AND HAD TO BE REMOVED. A LOT OF FORCE AND TWISTING HAD TO BE APPLIED TO REMOVE THE NAIL. THE MEDULLARY CAVITY WAS EXTENDED BY DRILLING AND A NEW NAIL COULD BE PLACED. DAMAGE ON THE INSERTION HANDLE HAS BEEN REPORTED. SURGERY DELAY: 10 MIN. NO ADVERSE PATIENT HARM. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1206426 HN MULTILOC Ø7 IZQ CAN L255 TAN ROD,FIXATION,INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH 4L05454 07611819501201

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR