BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 4250082 · Received November 14, 2014

    Report

    Report Number
    3003787298-2014-10060
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Report Date
    October 22, 2014
    Manufacturer
    SYNTHES JENNERSVILLE
    Product Code
    HTJ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 8-MAR-2011. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN. AN ADDITIONAL EVALUATION WAS PERFORMED: THE CUSTOMER REPORTED THE METAL THAT HOOKED TO THE BONE WAS SNAPPED OFF. THE REPAIR TECHNICIAN REPORTED THE TIP WAS BROKEN. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THIS ITEM WAS FORWARDED TO THE COMPLAINT HANDLING UNIT. THE EVALUATION WAS CONFIRMED. 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

    ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THE 319.006 DEPTH GAGE IS DESIGNED TO MEASURE THE 2.0 & 2.4MM X 50MML CORTEX SCREW-HOLE DEPTHS USED FOR PLATE FIXATION PROCEDURES FEATURED IN OVER 20 TECHNIQUE GUIDES REQUIRING SCREWS OF THIS TYPE. THE 319.006 LOT 6608633 CORTEX SCREW DEPTH GAGE WAS RECEIVED WITH THE DISTAL TIP BROKEN OFF AND LOOSE IN THE PACKAGE. GENTLE WEAR MARKS EXIST FROM USE AS WELL. THE RECEIVED DEVICE WAS MANUFACTURED MARCH 2011, IS OVER 3 YEARS OLD. THE DISTAL PIN WHICH WAS RECEIVED BROKEN OFF AND IT OCCURRED AT SOME POINT OUTSIDE OF SURGERY. THE DRAWING FROM TIME OF MANUFACTURE WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN AND DIMENSIONAL CONFORMITY (LESS THE DISTAL TIP) WHEN USED AS RECOMMENDED. THIS DELICATE MEASURING INSTRUMENT MUST BE HANDLED WITH CONSIDERABLE CARE AND LIKELY THE METHOD OF USE AND HANDLING HAS LED TO THIS COMPLAINT. HEALTH PROFESSIONAL INADVERTENTLY CHECKED; SHOULD BE ONLY COMPANY REPRESENTATIVE 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. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE METAL HOOKS THAT ATTACH TO THE BONE ON THE DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS HAVE SNAPPED OFF. THIS EVENT DID NOT OCCUR DURING SURGERY AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WILL ME MADE AVAILABLE FOR THIS COMPLAINT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737601 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE,DEPTH HTJ SYNTHES JENNERSVILLE 6608633

    Patients

    Seq Age Sex Outcome Treatment
    1