BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MULTILOC END CAP F/MULTILOC NAIL/0MM EXTENSION-STERILE

    MDR report key: 10771440 · Received November 2, 2020

    Report

    Report Number
    8030965-2020-08482
    Event Type
    Malfunction
    Date Received
    November 2, 2020
    Date of Event
    October 7, 2020
    Report Date
    October 7, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819431263
    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. INVESTIGATION SUMMARY INVESTIGATION SITE: CQ ZUCHWIL, SELECTED FLOW: DAMAGED: VISUAL / EXAMPLES: DEFORMED/BENT/CRACKED/BROKEN. VISUAL INSPECTION: THE EVALUATION HAS SHOWN THAT THE FIRST THREAD FLANK OF THE RECEIVED END CAP IS STRIPPED. THERE ARE ALSO STRESS MARKS AT OUTER DIAMETER AT THE FOREFRONT OF THE CAP VISIBLE. DIMENSIONAL INSPECTION: CHECKED DIMENSIONS WITH CALIPER 3-01-20766 PER DRAWING: OUTER DIAMETER 1 SPECIFICATION/MEASURED: = PASS OUTER DIAMETER 2 SPECIFICATION/ MEASURED: = PASS THE RELEVANT DIMENSIONS OF THE THREAD CANNOT BE VERIFIED ANYMORE DUE TO THE DAMAGE. DOCUMENT/SPECIFICATION REVIEW: DRAWING WAS REVIEWED TO VERIFIED THE RELEVANT DIMENSIONS OF THE END CAP. THE DRAWING IS IN PLACE SINCE JULY 2014, WHICH SPEAKS AGAINST A DESIGN RELATED ISSUE. THE LOT 50P4535 WAS MANUFACTURED IN JUNE 2020 WITH A LOT SIZE OF 50 PIECES, ALL DEVICES ARE DISTRIBUTED AND WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THIS ARTICLE- AND LOT COMBINATION. INVESTIGATION CONCLUSION: THE COMPLAINT IS CONFIRMED AS THE THREAD OF THE END CAP IS DAMAGED AS COMPLAINED. DURING THE PERFORMED EVALUATION NO MANUFACTURING RELATED ISSUE COULD BE DETECTED. BASED ON THE PROVIDED INFORMATION THE EXACT CAUSE OF THIS OCCURRENCE CANNOT BE DEFINED. BASED ON THE APPEARANCE OF THE DAMAGED THREAD IT CAN ONLY BE ASSUMED THAT CROSS THREADING IN COMBINATION WITH A HIT DURING THE INSERTION ATTEMPT DID LEAD TO THE DAMAGE OF THE FIRST THREAD FLANK. 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 LOT PART NUMBER: 04.019.000S, SYNTHES LOT NUMBER: 50P4535, MANUFACTURING SITE: MEZZOVICO, RELEASE TO WAREHOUSE DATE: JUNE 15, 2020, EXPIRY DATE: JUNE 1, 2030. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE NOT FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES RELATED TO THE COMPLAINED ISSUE 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 HAS BEEN 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) 2020, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION SURGERY FOR PROXIMAL HUMERUS FRACTURE WITH THE ENDCAP. DURING THE ENDCAP INSERTION, THE SURGEON HAD DIFFICULTY IN INSERTING THE ENDCAP. THE SURGEON CHECKED THE ENDCAP AND FOUND THAT THE THREAD OF THE ENDCAP WAS DAMAGED. THE SURGEON INSERTED ANOTHER ENDCAP (2MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN THIRTY (30) MINUTES DELAY. PATIENT OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TI MULTILOC END CAP F/MULTILOC NAIL/0MM EXTENSION-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1234482 TI MULTILOC END CAP F/MULTILOC NAIL/0MM EXTENSION-STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB OBERDORF SYNTHES PRODUKTIONS GMBH 50P4535 07611819431263

    Patients

    Seq Age Sex Outcome Treatment
    1