BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 5265559 · Received December 3, 2015

    Report

    Report Number
    1719045-2015-10789
    Event Type
    Malfunction
    Date Received
    December 3, 2015
    Report Date
    November 12, 2015
    Manufacturer
    SYNTHES MONUMENT
    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 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, SERVICE HISTORY REVIEW WAS ATTEMPTED: PART NO. 319.006, LOT NO: 6220623, NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 15-SEP-2009. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. 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

    SUBJECT DEVICE HAS BEEN RECEIVED AND AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: THE FOLLOWING WAS RECEIVED: DEPTH GAUGE (PART # 319.006 / LOT # 6220623), DEPTH GAUGE (PART # 319.006 / LOT # 6823060), THE RETURNED DEPTH GAUGES SHOWS REGULAR USE DURING ITS LIFESPAN. THE HOOKED NEEDLE STEM OF THE DEVICES ARE NOT BROKEN OFF AT THE BASE OF THE BLACK BODY, NOR ARE THEY LOOSE. THE DEVICES ARE CALIBRATED CORRECTLY. BOTH DEVICES EXHIBIT SOME RESISTANCE TO MOVEMENT, CAUSING THE SLIDING ACTION TO NOT BE SMOOTH. THIS PARTICULAR DEPTH GAUGE IS PART OF AT LEAST 14 TECHNIQUE GUIDES, INCLUDING THE 2.4 MM VARIABLE ANGLE LCP DISTAL RADIUS SYSTEM AND IS USED TO MEASURE THE DEPTH OF THE HOLES FOR THE 2.0MM/2.4MM SCREWS TO ENSURE THE CORRECT SCREW LENGTH IS USED DURING THE PROCEDURE. THE INFORMATION IS PROVIDED PER THE 2.4 MM VARIABLE ANGLE LCP DISTAL RADIUS SYSTEM TECHNIQUE GUIDE. THE EXACT CAUSE FOR THE DAMAGE COULD NOT BE DETERMINED, BUT IT IS LIKELY DUE TO WEAR FROM USE AND REPEATED STERILIZATION CYCLES OVER THE LIFE OF THE DEVICE. NO MANUFACTURING OR DESIGN ISSUES WERE NOTED DURING THE INVESTIGATION. THE DESIGN DETERMINED TO BE ADEQUATE FOR ITS INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED. THIS COMPLAINT IS CONFIRMED. THIS INVESTIGATION SUMMARY IS APPROVED. A SERVICE & REPAIR HISTORY/MAINTENANCE REVIEW WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES INDICATES THAT: THE CUSTOMER REPORTED THE ITEM WAS STICKING AND NOT SLIDING PROPERLY. THE REPAIR TECHNICIAN REPORTED THE GAUGE WAS WORN. WORN OUT PARTS IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO THE COMPLAINT HANDLING UNIT. THE EVALUATION WAS CONFIRMED. 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

    THE SERVICE AND REPAIR DEPARTMENT DOCUMENTED THAT DURING A FIFTH METATARSAL OPEN REDUCTION INTERNAL FIXATION SURGERY THE DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS WAS STICKING AND NOT SLIDING PROPERLY. A BACK UP DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY, BUT LATER IN STERILE PROCESSING THE BACK UP WAS FOUND TO BE EXPERIENCING THE SAME ISSUE, STICKING AND NOT SLIDING. THERE ARE 2 PARTS FOR THIS COMPLAINT. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795053 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE, DEPTH HTJ SYNTHES MONUMENT 6220623

    Patients

    Seq Age Sex Outcome Treatment
    1