BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 6022484 · Received October 12, 2016

    Report

    Report Number
    2530088-2016-10287
    Event Type
    Malfunction
    Date Received
    October 12, 2016
    Report Date
    September 22, 2016
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HTJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PART 319.006, LOT 5252431: RELEASE TO WAREHOUSE DATE: JUNE 08, 2006. MANUFACTURED BY SYNTHES (B)(4). REVIEW OF THE DEVICE HISTORY RECORDS (DHR) SHOWED THERE ARE POTENTIAL ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A NON-CONFORMANCE REPORT WAS WRITTEN FOR VARIOUS LOTS INCLUDING 5252431 AN UNDERSIZED MAJOR DIAMETER OF THE THREAD FEATURE ON THE NEEDLE COMPONENT. AS THE COMPLAINT DESCRIPTION NOTES THAT THE NEEDLE FAILED, RELEVANCE TO THE COMPLAINT CONDITION CANNOT BE DETERMINED UNTIL THE PRODUCT IS RETURNED FOR INVESTIGATION; HOWEVER, THE BENDING STRENGTH OF AN EXTERNAL THREAD ELEMENT WOULD BE A FUNCTION OF THE SIZE OF THE MINOR DIAMETER, NOT THE MAJOR DIAMETER SINCE THE MINOR DIAMETER REPRESENTS THE WORST CASE CROSS SECTION IN TERMS OF BENDING STRENGTH. ALL SUBCOMPONENT DHRS WERE REVIEWED AND FOUND TO BE WITHOUT ISSUE DURING THE MANUFACTURING PROCESS THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS PART NUMBER 319.006 WITH LOT NUMBER(S) 5252431 IS A LOT/BATCH CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS (B)(6) 2006. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 A DEPTH GAUGE HAS A BROKEN NEEDLE. IT IS UNKNOWN HOW AND WHERE THIS OCCURRED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671305 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE, DEPTH HTJ SYNTHES BRANDYWINE 5252431

    Patients

    Seq Age Sex Outcome Treatment
    1