BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PITUITARY RONGEUR-STRAIGHT 4MM WIDTH

    MDR report key: 11805633 · Received May 11, 2021

    Report

    Report Number
    8030965-2021-03792
    Event Type
    Malfunction
    Date Received
    May 11, 2021
    Report Date
    April 15, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTD
    UDI-DI
    10705034712673
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 NUMBER: 03.605.527, LOT NUMBER: T182059, MANUFACTURING SITE: TUTTLINGEN, RELEASE TO WAREHOUSE DATE: 02-APR-2019. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE PITUITARY RONGEUR-STRAIGHT 4MM WIDTH (P/N: 03.605.527, LOT #: T182059) WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION OF THE PHYSICAL DEVICE AND PICTURES PROVIDED, IT WAS OBSERVED THAT THERE WERE 2X2 POINTS WITH OVAL ON THE DISTAL TIP AND THE DISTANCE BETWEEN THE POINTS SEEMS TO BE VERY EVEN. THERE WERE SCRATCHES ON THE DEVICE BUT HAVE NO IMPACT ON THE DEVICE FUNCTIONALITY. NO OTHER ISSUES WERE OBSERVED WITH THE RETURNED DEVICE. DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION CAN BE PERFORMED DUE TO POST-MANUFACTURING DAMAGE. FURTHERMORE, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY, BECAUSE OF THE DESIGN OF THE DEVICE. DOCUMENT/SPECIFICATION REVIEW BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED STRAIGHT PITUITARY, 4MM. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION WAS CONFIRMED FOR THE PITUITARY RONGEUR-STRAIGHT 4MM WIDTH (P/N: 03.605.527, LOT #: T182059). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. THE SHAPE OF THE RESIDUE OR IMPRINT IS NOT TYPICAL FOR THE MANUFACTURE OF THE DEVICE, THE POTENTIAL CAUSE COULD BE POSSIBLE CONTACT WITH SOMETHING ELSE DURING CLEANING AND STERILIZATION. 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 · 1

    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 AN UNKNOWN DATE, THE DEVICE WAS DISCOVERED TO HAVE FOUR BLACK DOTS AND A RING AROUND IT. THIS FOREIGN SUBSTANCE WAS FOUND AND THE DEVICE WAS REJECTED. NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) PITUITARY RONGEUR-STRAIGHT 4MM WIDTH. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702567 PITUITARY RONGEUR-STRAIGHT 4MM WIDTH FORCEPS HTD SYNTHES GMBH 03.605.527 T182059 10705034712673

    Patients

    Seq Age Sex Outcome Treatment
    1