BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERNAL ZIPFIX WITH NEEDLE STERILE/20 PACK

    MDR report key: 8317236 · Received February 7, 2019

    Report

    Report Number
    8030965-2019-60743
    Event Type
    Injury
    Date Received
    February 7, 2019
    Date of Event
    January 1, 2019
    Report Date
    January 21, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    JDQ
    UDI-DI
    07611819618053
    PMA / PMN Number
    K110789
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE INITIAL COMPLAINT WAS REVIEWED AND FOUND NOT REPORTABLE. THERE WERE ONLY 5 IMPLANTS THAT BROKE AND THE PART NUMBER 08.501.001.20S REPRESENT QUANTITIES OF 20 THEREFORE ALL 5 QUANTITIES WILL BE CAPTURED UNDER MFR 8030965-2019-60739. 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

    EXACT DATE IS UNKNOWN. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, PATIENT UNDERWENT IMPLANT PROCEDURE. POST-OPERATIVE, ON (B)(6) 2019, PATIENT UNDERWENT REVISION SURGERY DUE TO FIVE (5) STERNAL ZIPFIX CABLE TIE WITH NEEDLE THAT WERE TORN OUT AT THE LOCK OF THE ZIPFIX AND DELAYED HEALING. THE ISSUE WAS DISCOVERED DUE TO THE PAIN, INSTABILITY AND STRIPPED EXPERIENCED BY THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY REPORTED. PATIENT STATUS WAS GOOD. CONCOMITANT DEVICE: STERNAL ZIPFIX (PART 08.501.001.20S, LOT 9052978, QUANTITY 5). THIS REPORT IS FOR ONE (1) STERNAL ZIPFIX. THIS IS REPORT 2 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108837 STERNAL ZIPFIX WITH NEEDLE STERILE/20 PACK CERCLAGE FIXATION JDQ OBERDORF SYNTHES PRODUKTIONS GMBH 9052978 07611819618053

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention