BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 34MM

    MDR report key: 9261564 · Received October 31, 2019

    Report

    Report Number
    8030965-2019-69868
    Event Type
    Injury
    Date Received
    October 31, 2019
    Report Date
    October 9, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819152106
    PMA / PMN Number
    K103002
    Adverse Event
    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. 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.

    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: PART: 412.113S, LOT: L882125, MANUFACTURING SITE: GRENCHEN, RELEASE TO WAREHOUSE DATE: 15. MAY 2018, EXPIRY DATE: 01. MAY 2028. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE RETURNED LOCKING SCREW WAS FOUND INTACT AND THEREFORE THE FLOW CHART ADVERSE EVENT (NO REPORTED PRODUCT PROBLEM) WAS SELECTED FOR THIS INVESTIGATION. AT THE PC LEVEL ARE ATTACHED THE PICTURES OF THE RECEIVED ARTICLES / CONDITION. INVESTIGATION SITE: CQ ZUCHWIL. SELECTED FLOW: ADVERSE EVENT (NO REPORTED PRODUCT PROBLEM). VISUAL INSPECTION: THE ARTICLE IS IN USED CONDITION. SUMMARY: THE LOCKING SCREW IS FINALLY RETURNED AS A CONCOMITANT DEVICE WITHOUT AN ALLEGED COMPLAINT CONDITION. UPON VISUAL INSPECTION, THERE IS NO EVIDENCE THAT THIS DEVICE CONTRIBUTED TO THE COMPLAINT CONDITION WITH THE ABOVE MENTIONED OCCURRENCES. THEREFORE NO ADDITIONAL INVESTIGATION WILL BE PERFORMED ON THIS DEVICE, THE BROKEN LOCKING SCREWS ARE INVESTIGATED IN THE OTHER PRODUCT COMPLAINT (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 · 0

    THIS (B)(4) WAS CREATED TO CAPTURES THE TEN (10) OUT OF SEVENTEEN (17) DEVICES, WHILE (B)(4) WAS CREATED TO CAPTURE THE SEVEN (7) OUT OF SEVENTEEN (17) DEVICES DUE TO DELAYED HEALING.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: KTT. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION BUT HAS YET TO BE RECEIVED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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. 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) 2018, THE PATIENT UNDERWENT INTERNAL FIXATION SURGERY WITH THE PLATE. ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL SURGERY. THE SIX (6) LOCKING SCREWS BROKE IN POST-OPERATIVE TIME . EACH OF THE SIX SCREWS WAS BROKEN AT THEIR NECKS WHEN THE SURGEON TRIED TO REMOVE EACH OF THE SIX SCREWS WITH A SCREWDRIVER. SURGEON SAID THAT THE SCREW MAY BE UNDER LOAD BECAUSE THE BONE UNION WAS DELAY. THE HEALING WAS DELAYED FROM THE SURGEON ORIGINALLY EXPECTED, AND IT MIGHT HAVE CAUSED THE SCREW BREAKAGE DURING REMOVAL. THIS IS UNKNOWN IF THE SURGERY WAS DELAYED AND PATIENT OUTCOME. THIS REPORT IS FOR 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055406 3.5MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 34MM ROD,FIXATION,INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH L882125 07611819152106

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention