BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 3146608 · Received June 5, 2013

    Report

    Report Number
    2530088-2013-00869
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Report Date
    May 9, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HTJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE DEVICE HISTORY RECORD WAS REVIEWED AND REWORK WAS FOUND ON P/N 319.006.03 LOT #6113829. THE REWORK PERFORMED INSPECTION ON THE L1 SUPPLIER FEATURE. THE L1 FEATURE WAS FOUND NONCONFORMING AND A NCR WAS CREATED. THE NONCONFORMANCE FOR L1 WAS REVIEWED BY THE PDE AND ACCEPTED USE AS IS BECAUSE THE CRITICAL DIMENSION 74.50 +/-0.15 CAN STILL BE MAINTAINED ON THE ASSEMBLY WITH THE OVERSIZE PARTS. THE RELEVANCE OF THIS NONCONFORMANCE IS NOT ABLE TO BE DETERMINED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ADDITIONAL NARRATIVE: DEVICE IS AN INSTRUMENT AND IS NOT AN IMPLANT/EXPLANT. THE ITEM WAS RECEIVED WITH A BROKEN TIP. NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE SERVICE AND REPAIR DEPARTMENT, THE TIP OF THE DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS BROKE OFF. IT IS NOT KNOWN HOW THE TIP BECAME BROKEN, POSSIBLY DURING CLEANING. THIS COMPLAINT IS NOT FOR A WARRANTY REPLACEMENT ONLY. THIS EVENT DID NOT CONTRIBUTE TO A DEATH OR INJURY, WHETHER THE DEVICE WAS MISUSED OR NOT. THE DEVICE DID NOT MALFUNCTION DURING SURGERY WHILE BEING USED ON PATIENT. THE REPORTED INSTANCE WAS NOT AN ANTICIPATED SERVICE OR WARRANTY REPLACEMENT ISSUE. THIS IS 1 OF 1 REPORT FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247771 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS HTJ SYNTHES BRANDYWINE 6135832

    Patients

    Seq Age Sex Outcome Treatment
    1