BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 4844519 · Received June 15, 2015

    Report

    Report Number
    3003787298-2015-10034
    Event Type
    Malfunction
    Date Received
    June 15, 2015
    Report Date
    June 2, 2015
    Manufacturer
    SYNTHES JENNERSVILLE
    Product Code
    HTJ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. A REVIEW OF THE SERVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS CURRENTLY PENDING COMPLETION. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: A SERVICE AND REPAIR EVALUATION WAS PERFORMED FOR THE SUBJECT DEVICE (PART NUMBER 319.006, DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS, LOT NUMBER 7378714). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION OF ¿THE NEEDLE BROKE OFF.¿ THE REPAIR TECHNICIAN REPORTED ¿TIP BROKEN¿ AS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THIS ITEM WAS FORWARDED TO THE SYNTHES COMPLAINT HANDLING UNIT FOR ADDITIONAL EVALUATION. THE EVALUATION WAS CONFIRMED. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE. THE RETURNED DEVICE WAS RECEIVED WITH THE NEEDLE TIP BROKEN AS COMPLAINED. THE DEPTH GAUGE IS PART OF 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 PER THE TECHNIQUE GUIDE. THE PRODUCT DRAWING WAS REVIEWED DURING THE INVESTIGATION. THE THICKNESS OF THE NEEDLE (1.25 MM) IS DRIVEN BY THE FACT THAT THE NEEDLE MUST FIT INTO A DRILLED HOLE OF 1.5 MM, AND THE LENGTH (80 MM) IS DETERMINED SO THE SLIDER CAN MEASURE SCREWS UP TO 40 MM. THE MATERIAL OF THE NEEDLE PROBE COMPONENT IS EXTRA HARD (B)(4), WHICH IS AN APPROPRIATE MATERIAL FOR AN INSTRUMENT COMPONENT OF THIS TYPE. THE RETURNED DEPTH GAUGE SHOWS SIGNS OF NORMAL USE. THE HOOKED NEEDLE STEM OF THE DEVICE IS BROKEN OFF AT THE BASE OF THE BLACK BODY BROKEN (THE BROKEN STEM IS APPROXIMATELY 75MM IN LENGTH) AND WAS RETURNED. EXCESSIVE WEIGHT BEING PLACED ONTO THE NEEDLE DURING STERILE PROCESSING OR OFF AXIS INSERTION MAY HAVE CAUSED THE COMPLAINT. THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. 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: SERVICE HISTORY REVIEW: LOT 7378714: NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. 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 THE NEEDLE ON TWO (2) DEPTH GAUGES FOR 2.0MM AND 2.4MM SCREWS BROKE OFF. THE ISSUE WAS DISCOVERED DURING THE CLEANING PROCESS. NO PATIENT OR SURGICAL INVOLVEMENT REPORTED. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387159 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE, DEPTH HTJ SYNTHES JENNERSVILLE 7378714

    Patients

    Seq Age Sex Outcome Treatment
    1