BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MULTILOC END CAP F/MULTILOC NAIL/2MM EXTENSION-STERILE

    MDR report key: 8633264 · Received May 22, 2019

    Report

    Report Number
    8030965-2019-64372
    Event Type
    Malfunction
    Date Received
    May 22, 2019
    Date of Event
    April 24, 2019
    Report Date
    April 24, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819431270
    PMA / PMN Number
    K103002
    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, H4, H6: A REVIEW OF THE DEVICE HISTORY RECORD DEVICE HISTORY LOT, PART: 04.019.002S, LOT: 5944782, MANUFACTURING SITE: SALZBURG, RELEASE TO WAREHOUSE DATE: 16.JAN.2018, EXPIRY DATE: 01.JAN.2028. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: INVESTIGATION SUMMARY INVESTIGATION SITE: CQ ZUCHWIL. SELECTED FLOW: DAMAGE / DEFORMED. VISUAL INVESTIGATION: ONE 04.019.002S / MULTILOC END CAP F/MULTILOC HN/PHN EXTENDED WAS RECEIVED FOR INVESTIGATION. THE DEVICE IS INTACT BUT SHOWS VARIOUS DAMAGE AND WEAR. THE M6X1 THREAD IS UNUSABLE BECAUSE OF THE DAMAGE. THE FIRST THREAD FLANK IS PARTIALLY TORN AND THERE ARE STRIATIONS ON THE GUIDING PIVOT RUN-IN AREA. THE STARDRIVE RECESS AND THE FRONT FACE SHOW MARKS / STRIATIONS OF USE. DIMENSIONAL INSPECTION: DRAWING/SPECIFICATION REVIEW: DIMENSIONS REVIEWED REFERRING TO DRAWING SE_297630 VERSION E. THE MANUFACTURING DOCUMENTS SHOW THAT THE DEVICE MET FULLY TO OUR SPECIFICATIONS AT THE TIME OF MANUFACTURING IN JANUARY 2018 AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. CONCLUSION: AS THE THREAD OF THE END CAP IS DAMAGED IT CANNOT BE FIXED TO THE NAIL ANYMORE; THE RECEIVED CONDITION AGREE WITH THE COMPLAINT DESCRIPTION AND THE COMPLAINT THEREFORE IS CONFIRMED. THE MANNER OF DAMAGE AND WEAR PRESENT THE APPLICATION OF MECHANICAL OVERLOAD AND CROSS-THREADING DURING INSERTION. THE MOST LIKELY ROOT CAUSE IS THE APPLICATION OF EXCESSIVE FORCES THAT OCCUR DURING AN ALIGNMENT ERROR DURING SCREWING. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. B5: CONCOMITANT PRODUCT (UNK - NAILS: MULTILOC HUMERAL) WAS VOIDED AS THIS IS ALREADY CAPTURED AS IMPACTED PRODUCT. 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

    7/9/2019: UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON (B)(6) 2019 DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE USING A MULTILOC HUMERAL NAIL SYSTEM FOR A PATIENT WITH A PROXIMAL HUMERAL FRACTURE, THE END CAP COULD NOT BE INSERTED INTO THE UNKNOWN NAIL. THE SURGEON TRIED TO INSERT THE END CAP INTO THE UNKNOWN NAIL, HOWEVER, THE END CAP COULD NOT BE CAUGHT IN THE UNKNOWN NAIL PROPERLY. THE END CAP WAS REMOVED AND ANOTHER END CAP WAS INSERTED SMOOTHLY INTO THE UNKNOWN NAIL WITHOUT PROBLEMS. WHEN THE SURGEON CHECKED THE REMOVED END CAP, THE SURGEON FOUND OUT THAT ONE (1) METALLIC MATERIAL ADHERED TO THE END CAP AND THE TWO (2) THREADS OF THE END CAP WAS DAMAGED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF THIRTY (30) MINUTES. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT REPORTED. PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

    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 THAT ON (B)(6) 2019 DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE USING A MULTILOC HUMERAL NAIL SYSTEM FOR A PATIENT WITH A PROXIMAL HUMERAL FRACTURE, THE END CAP COULD NOT BE INSERTED INTO THE UNKNOWN NAIL. THE SURGEON TRIED TO INSERT THE END CAP INTO THE UNKNOWN NAIL, HOWEVER, THE END CAP COULD NOT BE CAUGHT IN THE UNKNOWN NAIL PROPERLY. THE END CAP WAS REMOVED AND ANOTHER END CAP WAS INSERTED SMOOTHLY INTO THE UNKNOWN NAIL WITHOUT PROBLEMS. WHEN THE SURGEON CHECKED THE REMOVED END CAP, THE SURGEON FOUND OUT THAT ONE (1) METALLIC MATERIAL ADHERED TO THE END CAP AND THE TWO (2) THREADS OF THE END CAP WAS DAMAGED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF THIRTY (30) MINUTES. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT REPORTED. PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN NAIL ( PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) TI MULTILOC END CAP F/MULTILOC NAIL/2MM EXTENSION-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424101 TI MULTILOC END CAP F/MULTILOC NAIL/2MM EXTENSION-STERILE ROD,FIXATION,INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH 5944782 07611819431270

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NAIL