BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 4755677 · Received May 7, 2015

    Report

    Report Number
    2530088-2015-10159
    Event Type
    Malfunction
    Date Received
    May 7, 2015
    Report Date
    April 17, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HTJ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED; NO CONCLUSIONS COULD BE DRAWN AS THE DEVICE IS ENTERING THE COMPLAINT SYSTEM. SERVICE HISTORY REVIEW: LOT #4911448 - NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS JANUARY 11, 2005. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. DEVICE 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

    SERVICE & REPAIR EVALUATION: THE CUSTOMER REPORTED THE TIP WAS BROKEN. THE REPAIR TECHNICIAN REPORTED TIP BROKEN AS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. PRODUCT INVESTIGATION SUMMARY: THE COMPLAINT CONDITION FOR THE DEPTH GAUGE (PART 319.006 / LOT 4911448) AND THE DEPTH GAUGE (PART 319.006 / LOT 6004398) WAS LIKELY CAUSED BY ROUGH OR IMPROPER HANDLING DURING STERILE PROCESSING OR SURGERY; HOWEVER, THIS COMPLAINT IS NOT A RESULT OF ANY DESIGN RELATED DEFICIENCY. THE DEPTH GAUGE (PART 319.006) IS AN INSTRUMENT ROUTINELY USED IN THE 2.4MM LOCKING COMPRESSION PLATE (LCP) DISTAL RADIUS SYSTEM. THE DEVICES WERE RETURNED WITH REPORTS THAT THE TIPS HAD BROKEN OFF. THIS CONDITION IS CONFIRMED; THE MEASURING WIRE IS BROKEN AT THE BASE WHERE IT MEETS THE REST OF THE DEPTH GAUGE ASSEMBLY ON BOTH DEVICES RENDERING THEM INCAPABLE OF MEASURING. IT IS LIKELY THAT ROUGH OR IMPROPER HANDLING DURING STERILE PROCESSING OR SURGERY HAS LED TO THIS COMPLAINT CONDITION. THE LOT 4911448 WAS MANUFACTURED IN JANUARY 2005 AND IS OVER TEN YEARS OLD. THE BALANCE OF THE DEVICE IS STILL IN FAIRLY GOOD CONDITION SHOWING ONLY SOME MILD WEAR. THE LOT 6004398 WAS MANUFACTURED IN OCTOBER 2008 AND IS OVER SIX YEARS OLD. THE BALANCE OF THE DEVICE IS IN FAIR CONDITION AND SHOWS SOME WEAR. THE ASSOCIATED DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION, AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. THE CONDITION OF THE RETURNED DEVICES DOES AGREE WITH THE COMPLAINT DESCRIPTION. WHETHER THE COMPLAINT CONDITION FOR THESE DEVICES CAN BE REPLICATED IS NOT APPLICABLE FOR THIS CONDITION. DEVICE 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 THE TIPS OF TWO (2) DEPTH GAUGES FOR 2.0MM AND 2.4MM SCREWS WERE BROKEN OFF. THE DISCOVERY WAS MADE OUTSIDE OF THE OPERATING ROOM WITH NO SURGICAL OR PATIENT INVOLVEMENT. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300633 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE, DEPTH HTJ SYNTHES BRANDYWINE 4911448

    Patients

    Seq Age Sex Outcome Treatment
    1