BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMMER 500 GRAMS

    MDR report key: 6551538 · Received May 8, 2017

    Report

    Report Number
    9680938-2017-10106
    Event Type
    Malfunction
    Date Received
    May 8, 2017
    Report Date
    June 9, 2017
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    FZY
    UDI-DI
    10886982202802
    PMA / PMN Number
    PREAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (HAMMER 500 GRAMS, PART NUMBER 399.42, LOT NUMBER T935003). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING THIS COMPLAINT IS CONFIRMED. COMPLAINT IS FOR 15 MALLETS, HOSPITAL STATED 12 MALLETS WOULD BE RETURNED, HOWEVER ONLY 11 MALLETS WERE RECEIVED AT CQ FOR INVESTIGATION. WHETHER THIS COMPLAINT CAN BE REPLICATED AT CUSTOMER QUALITY (CQ) IS NOT APPLICABLE FOR THIS COMPLAINT CONDITION. A CHEMICAL ANALYSIS OF RESIDUE WAS PERFORMED ON THE RETURNED DEVICES. THE RESULTS IN THE ATTACHED CHEMICAL REPORT STATES: THE RESIDUE RECOVERED FROM THE HANDLE CLOSELY MATCHES AN ORGANIC LIPID. WHILE SOME ASPECTS ARE IN COMMON WITH LUBRICANTS USED IN REPROCESSING, THE SPECTRAL FEATURES ARE UNIQUE TO MATERIAL OF BIOLOGICAL ORIGIN. THE CONCLUSION IN THE ATTACHED CHEMICAL REPORT STATES: "BASED ON THE SPECTRAL EVIDENCE, THE MANNER OF USE OF THE DEVICE AND THE CONTRIBUTION OF WEAR WHICH RESULTED IN GREATER POROSITY, THE MATERIAL RECOVERED FOR ANALYSIS IS CONSISTENT WITH NON-POLAR CONSTITUENTS OF SURGICAL SOILS WHEN INFRARED SPECTRAL ANALYSIS IS USED FOR IDENTIFICATION". DHR REVIEWS WERE PERFORMED FOR DEVICES WITH KNOWN LOT#'S AND NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. APPROPRIATE ACTIONS ARE BEING TAKEN BASED ON INVESTIGATION RESULTS. THE ROOT CAUSE HAS BEEN DETERMINED TO BE PRODUCT DESIGN BASED ON THE SPECTRAL EVIDENCE, THE MANNER OF USE OF THE DEVICE AND THE CONTRIBUTION OF WEAR WHICH RESULTED IN GREATER POROSITY WHICH CONTRIBUTED TO THE FOREIGN MATERIAL DEPOSITS. 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

    COMPLAINT IS FOR 15 MALLETS, HOSPITAL STATED 12 MALLETS WOULD BE RETURNED, AND ONLY 12 MALLETS WERE RECEIVED AT CUSTOMER QUALITY (CQ) FOR INVESTIGATION 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

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. MANUFACTURING DATE: 11-MAR-2009. REVIEW OF THE DEVICE HISTORY RECORD OF (B)(4) SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE THAT WOULD CONTRIBUTE TO THE ISSUE OUTLINED IN THIS COMPLAINT. THE DEVICE IS APPROX. 9 YEARS OLD. A REVIEW OF INSPECTION RECORDS AND CERTIFICATIONS, CONFIRM THAT THE, MATERIAL, COMPONENTS AND FINAL PRODUCT MET INSPECTION RECORDS AND CERTIFICATION. ALL (B)(4) PARTS OF THE LOT WERE CHECKED 100% FOR CRITICAL FEATURES AND FOR FUNCTION AT THE FINAL INSPECTION ON 11-MAR-2009. NO NCRS WERE GENERATED DURING MANUFACTURING. 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

    IT WAS REPORTED THAT THE WOODEN HANDLES ON FIFTEEN (15) 500 GRAM HAMMERS HAVE COME OUT OF STERILE PROCESSING APPEARING ¿GREASY¿. THIS CAUSES THE ENTIRE SET TO ALSO BECOME GREASY / COVERED IN THIS GREASY SUBSTANCE. THE GREASINESS APPEARS TO BE BETWEEN THE METAL AND THE WOOD. IT IS FURTHER REPORTED THAT THE FACILITY FOLLOWS THE MANUFACTURER¿S GUIDELINES FOR CLEANING. THE MALLETS HAVE BEEN TAKEN OUT OF CIRCULATION. NO PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) 500 GRAM HAMMER. THIS IS REPORT 6 OF 15 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332865 HAMMER 500 GRAMS HAMMER,SURGICAL FZY SYNTHES TUTTLINGEN T935003 10886982202802

    Patients

    Seq Age Sex Outcome Treatment
    1