BEUDAMED
    FDA Adverse Event Other Summary report: N

    CASTROVIEJO NEEDLE HOLDERS, 5 1/2", 10MM SMOOTH J

    MDR report key: 2288023 · Received May 25, 2007

    Report

    Report Number
    8010374-2007-00001
    Event Type
    Other
    Date Received
    May 25, 2007
    Report Date
    May 8, 2007
    Manufacturer
    SCHMID MEDIZINTECHNIK GMBH
    Product Code
    FHQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA LIFESCIENCES CORP. IS FILING ON BEHALF OF THE INITIAL DISTRIBUTOR (B)(4). CORRESPONDENCE SHOULD BE SENT TO: INTEGRA LIFESCIENCES CORP., (B)(4). THE MFR HAS BEEN NOTIFIED OF THE REPORTED COMPLAINT. ADDITIONAL INFO FROM THE IMPORTER REPORT: (B)(4): NOT RETURNED TO MANUFACTURER. INTEGRA LIFESCIENCES CORPORATION IS FILING ON BEHALF OF THE INITIAL DISTRIBUTOR (B)(4). AS REQUESTED, THE INSTRUMENT WAS THOROUGHLY CHECKED BY MR. (B)(4): WITH LOT # 2005370, (B)(4) INSTRUMENTS WERE MANUFACTURED IN OCTOBER 2005, AND DELIVERED TO THE DISTRIBUTOR ON (B)(4) 2005 WITH OUR INVOICE NO (B)(4). (B)(4). WE HAVE NOT RECEIVED A COMPLAINT OF THIS NATURE SO FAR, NEITHER FROM THE DISTRIBUTOR NOR FROM OTHER CUSTOMERS. THE PRODUCTION DOCUMENTS OF THIS LOT PROVE THAT THE RIGHT MATERIALS / COMPONENTS WERE USED AND THAT THE INSTRUMENT WAS MANUFACTURED IN ACCORDANCE WITH THE PRODUCTION SPECIFICATIONS. A (B)(4) TEST PERFORMED AT (B)(4). ON VISUAL INSPECTION OF THE INSTRUMENT WE NOTICED TWO PRESSURE MARKS IN THE REAR PART OF THE BOX-LOCK, WHICH COULD BE SIGNS OF SOME KIND OF MECHANICAL FORCE EFFECT THAT HAD BEEN APPLIED TO THE INSTRUMENT (POSSIBILITY REPAIR ATTEMPTS). SINCE EVERY SINGLE INSTRUMENT IS SUBJECT TO THOROUGH FINAL INSPECTION AT OUR END RESPECTIVELY TO INCOMING INSPECTION AT THE DISTRIBUTOR'S, IT CAN BE ASSUMED THAT THESE PRESSURE MARKS WERE CAUSED AT A LATER DATE. WE ALSO COULD FIND CORROSION ON THE POINT OF FRACTURE, WHAT LEADS TO THE ASSUMPTION THAT BEFORE THE TIP BROKE OFF, THERE HAD BEEN A CRACK. CONCLUSION: THE EXACT CAUSE FOR THE BREAK CANNOT BE CONCLUSIVELY DETERMINED. BASED ON OUR LONGTERM EXPERIENCE AS QUALIFIED INSTRUMENT MFR'S AND OUR ABOVE OBSERVATIONS, HOWEVER, IT COULD BE ASSUMED THAT OVERSTRESSING (STRESS CRACK CORROSION) OR IMPROPER USE (USING TOO THICK NEEDLES, HOLDING NEEDLES WITH THE REAR PART OF THE JAW WHAT LEADS TO A HIGH PRE-TENSION OF THE HANDLE SHANKS) COULD HAVE FINALLY CAUSED THE BREAK. AS STATED ABOVE, OUR PRODUCTION RECORDS INDICATE COMPLIANCE WITH ALL SPECIFICATIONS AND OUR TREND ANALYSIS REFLECTS NO PROBLEM WITH THIS PATTERN. THUS WE FEEL THAT NO PREVENTIVE ACTION IS TO BE TAKEN ON OUR PART.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE TIP OF THE INSTRUMENT BROKE OFF WHEN GRASPING SUTURE DURING AN EYE PLASTIC PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASTROVIEJO NEEDLE HOLDERS, 5 1/2", 10MM SMOOTH J NEEDLE HOLDER FHQ SCHMID MEDIZINTECHNIK GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1