BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANN SCREW MEASURING DEVICE FOR 6.5MM & 7.3MM CANN SCREWS

    MDR report key: 3201219 · Received July 2, 2013

    Report

    Report Number
    2520274-2013-04027
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HTJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PART/LOT NUMBER COMBINATION UNKNOWN AT SYNTHES (B)(4). WITHOUT A VALID LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE PRODUCT EVENT EVALUATION WAS CONDUCTED. PART CONDITION RECEIVED AS: SHOWS SIGNS OF USE BUT THE DEVICE IS NOT DAMAGED. THE ITEM RECEIVED WAS PART NUMBER 319.70 WITH LOT NUMBER A4GM802. THERE WAS NOTHING WRONG WITH DESIGN OF THIS DEPTH GAUGE. IF HOSPITAL WISHES TO USE SCREWS LONGER THEN 160MM, THE RECOMMENDATION IS TO ORDER A NEW DEPTH GAUGE.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS FOR TREATMENT, NOT DIAGNOSIS. DATE RETURNED TO MANUFACTURER: 7/23/2013. DATE RECEIVED BY MANUFACTURER: 7/23/2013. PART WAS NEVER MANUFACTURED WITH A LOT NUMBER, WHICH STARTS WITH A4 AT SYNTHES (B)(4). NO DHR REVIEW POSSIBLE. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS GOING ON; NO CONCLUSION COULD BE DRAWN. LOT # CHANGED FROM A4GM02 TO A4GM802.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS.(B)(4)

    Description of Event or Problem · 1

    THE MEASURING DEVICE FOR THE 7.3 MM CANNULATED SCREW WAS PROVIDING INACCURATE MEASUREMENTS DURING A PROCEDURE ON AN UNKNOWN DATE. REPORTEDLY, IT WAS SUGGESTED THAT EITHER THE GUIDE WIRE HAD ADVANCED A LITTLE AND IT WAS NOT RECOGNIZED WHEN MEASURING AT THE TIME OR THE SURGEON WAS NOT PUSHING THE DEPTH GAUGE DOWN ALL THE WAY TO THE BONE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301653 CANN SCREW MEASURING DEVICE FOR 6.5MM & 7.3MM CANN SCREWS HTJ SYNTHES USA A4GM802

    Patients

    Seq Age Sex Outcome Treatment
    1