BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LONG SCALPEL HANDLE

    MDR report key: 8245447 · Received January 14, 2019

    Report

    Report Number
    8030965-2019-59858
    Event Type
    Malfunction
    Date Received
    January 14, 2019
    Report Date
    December 19, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    GDZ
    UDI-DI
    07611819498891
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. PART 03.010.491, LOT 9854588: RELEASE TO WAREHOUSE DATE: NOVEMBER 20, 2015. SUPPLIER: AVALIGN TECHNOLOGIES-NEMCOMED. THE MATERIAL WAS REVIEWED AND THE HARDNESS VALUE WAS CONFIRMED TO MEET THE SPECIFICATION WITH NO RELEVANT NON-CONFORMANCE NOTED. NO NON-CONFORMANCE REPORTS (NCR'S) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. H3, H6: A PRODUCT INVESTIGATION WAS COMPLETED: VISUAL INSPECTION SHOWS THAT DISTAL TIP OF THE INSTRUMENT BROKE OFF AND WAS RETURNED. THE MATERIAL SURFACE AT BOTH FRACTURE SITE APPEARS HOMOGENEOUS WITH NO VOIDS OR ABNORMALITIES WHEN VIEWED UNDER 10X MAGNIFICATION. THE BALANCE OF THE DEVICE IS IN FAIR CONDITION WITH SIGNS OF WEAR AND TEAR. THE RECEIVED CONDITION DOES AGREE WITH THE COMPLAINT DESCRIPTION FOR BROKEN AND IS CONFIRMED. THE CAUSE OF THE ISSUE COULD NOT BE DETERMINED TO BE USE ERROR, MISUSE/ABUSE, NONCOMPLIANCE, POSTOPERATIVE TRAUMA. THE RELEVANT DIMENSIONS WERE MEASURED AND FOUND TO BE CONFORMING. THE RELEVANT DRAWINGS WERE REVIEWED. NO DESIGN OR MANUFACTURING DEFECT OR DEFICIENCY WAS OBSERVED DURING THE INVESTIGATION. A DEVICE HISTORY REVIEW, WAS PERFORMED FOR THE RETURNED INSTRUMENT¿S LOT NUMBER, AND NO NON-CONFORMANCE REPORTS (NCRS), NO MATERIAL REVIEW REPORTS (MRRS) OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBER WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE MATERIAL WAS REVIEWED AND THE HARDNESS VALUE WAS CONFIRMED TO MEET THE SPECIFICATION WITH NO RELEVANT NON-CONFORMANCE NOTED. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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. INITIAL REPORTER STATE, TOKYO-TO. MANUFACTURE RELEASE TO WAREHOUSE DATE: (B)(6) 2015. 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

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. OCCUPATION: INITIAL REPORTER IS A SYNTHES EMPLOYEE. 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. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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 (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2018, BEFORE AN UNKNOWN SURGERY, THE HOSPITAL FOUND THAT THE TIP OF THE SCALPEL HANDLE WAS BROKEN. THE HANDLE WAS NOT USED IN THE SURGERY. IT IS UNKNOWN HOW THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT IS FOR A SCALPEL HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38550 LONG SCALPEL HANDLE HANDLE, SCALPEL GDZ OBERDORF SYNTHES PRODUKTIONS GMBH 9854588 07611819498891

    Patients

    Seq Age Sex Outcome Treatment
    1