BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERNAL ZIPFIX W/NEEDLE PEEK SINGLE PACK

    MDR report key: 10214742 · Received June 30, 2020

    Report

    Report Number
    8030965-2020-04583
    Event Type
    Injury
    Date Received
    June 30, 2020
    Date of Event
    June 10, 2020
    Report Date
    June 18, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    JDQ
    UDI-DI
    07611819418400
    PMA / PMN Number
    K110789
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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, H6: PART: 08.501.001.01S, LOT: L864963, MANUFACTURING SITE: BETTLACH, SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 05.JUNE 2018, EXPIRY DATE: 01.MAY 2023 . A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. SUMMARY OF THE PRODUCT DEVELOPMENT EVALUATION: AFTER A VISUAL AND A FUNCTIONAL INSPECTION, THE COMPLAINT CONDITION WAS NOT ABLE TO BE REPLICATED. THERE WAS NOT SIGNIFICANT WEAR ON THE RETURNED PARTS, WHICH MIGHT HAVE INDICATED A POTENTIAL FOR MISUSE. AFTER A FULL DRAWING REVIEW, NO DESIGN DEFECTS WERE DETECTED. NO ACTION IS REQUIRED, AS THE COMPLAINT CANNOT BE REPLICATED, AND NO DESIGN DEFECTS WERE DETECTED. THE REVIEW OF THE DEVICE HISTORY RECORD REVEALED THAT THESE STERNAL ZIPFIXS WERE MANUFACTURED ACCORDING TO THE SPECIFICATIONS (LOT# 3L68993 IN APRIL 2019, LOT# L864963 IN JUNE 2018). THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS WITH NO NON-CONFORMITIES REPORTED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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: 08.501.001.01S, LOT: L864963, MANUFACTURING SITE: BETTLACH, SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: JUNE 05, 2018, EXPIRY DATE: MAY 01, 2023. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. SUMMARY OF THE PRODUCT DEVELOPMENT EVALUATION: AFTER A VISUAL AND A FUNCTIONAL INSPECTION, THE COMPLAINT CONDITION WAS NOT ABLE TO BE REPLICATED. THERE WAS NOT SIGNIFICANT WEAR ON THE RETURNED PARTS, WHICH MIGHT HAVE INDICATED A POTENTIAL FOR MISUSE. AFTER A FULL DRAWING REVIEW, NO DESIGN DEFECTS WERE DETECTED. NO ACTION IS REQUIRED, AS THE COMPLAINT CANNOT BE REPLICATED, AND NO DESIGN DEFECTS WERE DETECTED. THE REVIEW OF THE DEVICE HISTORY RECORD REVEALED THAT THESE STERNAL ZIPFIXS WERE MANUFACTURED ACCORDING TO THE SPECIFICATIONS (LOT 3L68993 IN APRIL 2019, LOT L864963 IN JUNE 2018). THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS WITH NO NON-CONFORMITIES REPORTED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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. H10 ADDITIONAL NARRATIVE: B5. H6: PATIENT CODE 3191 IS USED TO CAPTURE MODIFIED SURGICAL PLAN AND DEVICE FAILURE. 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

    UPDATE TO EVENT DESCRIPTION: IT WAS REPORTED THAT ON (B)(6) 2020, THAT DURING THE CORONARY ARTERY BYPASS SURGERY, TWO OUT OF FOUR ZIPFIX WERE UNABLE TO BE TIGHTENED. THE SURGEON HAS CHANGED THE STEEL WIRES TO COMPLETE THE SURGERY SUCCESSFULLY. THERE WAS NO SURGICAL DELAY REPORTED. THE PATIENT OUTCOME WAS REPORTED AS GOOD.

    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 ON AN UNKNOWN DATE THAT DURING THE CORONARY ARTERY BYPASS SURGERY, TWO OUT OF FOUR ZIPFIX UNABLE TO TIGHTENED. THE SURGEON HAS CHANGED THE STEEL WIRES TO COMPLETE THE SURGERY SUCCESSFULLY. THERE WAS NO SURGICAL DELAY WAS REPORTED. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: STERNAL ZIPFIX (PART# 08.501.001.01S, LOT# UNKNOWN, QUANTITY# 2); UNK - APPLICATION INSTRUMENT FOR STERNAL ZIPFIX (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) STERNAL ZIPFIX WITH NEEDLE STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676035 STERNAL ZIPFIX W/NEEDLE PEEK SINGLE PACK CERCLAGE FIXATION JDQ OBERDORF SYNTHES PRODUKTIONS GMBH L864963 07611819418400

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention STERNAL ZIPFIX W/NEEDLE PEEK SINGLE PACK| UNK - APPLICATION INSTRUMENT FOR STERNAL ZIPFIX| UNK - APPLICATION INSTRUMENT FOR STERNAL ZIPFIX