BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFRAME CONNECTROD F/HOLD-RINGS NOS. 38

    MDR report key: 16839555 · Received April 28, 2023

    Report

    Report Number
    8030965-2023-05454
    Event Type
    Malfunction
    Date Received
    April 28, 2023
    Date of Event
    February 9, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    FQP
    UDI-DI
    07611819098954
    PMA / PMN Number
    K993314
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. H10 ADDITIONAL NARRATIVE: H6: PHOTO INVESTIGATION: THE PHOTO WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE IMAGES. VISUAL ANALYSIS OF THE PHOTO REVEALED THAT SYNFRAME CONNECTROD F/HOLD-RINGS NOS. 38 HAD THAT THE INTERNAL THREADS OF THE LOCKING SCREW HEAVILY STRIPPED. BROKEN CONDITION WAS NOT OBSERVED. NO OTHER ISSUES WERE IDENTIFIED WITH THE DEVICE. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED FOR SYNFRAME CONNECTROD F/HOLD-RINGS NOS. 38. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. 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. H4, H6: DEVICE HISTORY RECORD (DHR) REVIEW CONDUCTED: PART: 387.345. LOT : L790894. RELEASE TO WAREHOUSE DATE : 13 JUNE 2018. EXPIRATION DATE : NA. SUPPLIER: NA. MANUFACTURING SITE: (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES 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. D4: LOT NUMBER. G1: PHYSICAL MANUFACTURER.

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H6: 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 · 0

    IT WAS REPORTED THAT ON FEBRUARY 9, 2023, THE DISTRIBUTOR REPORTED TWO INSTRUMENTS SPREADER FORCEPS CURV & SYNFRAME CONNECT ROD F/HOLD-RINGS NOS. 38 IN THEIR POSSESSION WERE BROKEN. NO FURTHER DETAILS ON HOW THE INSTRUMENTS BROKE WERE PROVIDED. IT WAS UNKNOWN IF THERE ANY PATIENT INVOLVEMENT OR NOT. THIS REPORT IS FOR ONE (1) SYNFRAME CONNECTING ROD. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1565921 SYNFRAME CONNECTROD F/HOLD-RINGS NOS. 38 LAMP, OPERATING-ROOM FQP SYNTHES GMBH L790894 07611819098954

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SPREADER FORCEPS CURV