BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 3881897 · Received June 18, 2014

    Report

    Report Number
    3003787298-2014-10027
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Report Date
    May 22, 2014
    Manufacturer
    SYNTHES JENNERSVILLE
    Product Code
    HTJ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: A SERVICE EVALUATION WAS PERFORMED. THE CUSTOMER REPORTED THE GAUGE WAS BROKEN OFF. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THIS ITEM WAS FORWARDED FOR FURTHER EVALUATION. 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

    EVENT DATE: UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A SERVICE HISTORY REVIEW WAS COMPLETED: 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THE DEPTH GAUGES WERE RECEIVED DISASSEMBLED AND IN SIMILAR CONDITIONS: THE NEEDLE IS BROKEN OFF THE GRADUATED BODY. THE SLIDE MECHANISM ON THE DEPTH GAUGE WAS TESTED AND THERE ARE NO ISSUES WITH THE SLIDING MECHANISM. THE OUTER BODY OF THE DEPTH GAUGE STAYS INTACT WHEN THE DEVICE IS HELD VERTICALLY. THERE ARE MULTIPLE NICKS AND SCRATCHES ON THE DEVICE CONSISTENT WITH NORMAL USE. ALSO, THE PROTECTING SLEEVE WAS RETURNED WITH THE DEVICE. 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 316SS, WHICH IS AN APPROPRIATE MATERIAL FOR AN INSTRUMENT COMPONENT OF THIS TYPE. A REVIEW OF THE DESIGN DRAWING INDICATES THAT THE RETURNED PARTS WERE MANUFACTURED TO THE RELEVANT DRAWINGS. THE COMPLAINT IS CONFIRMED FOR THE COMPLAINT CONDITION. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. EXCESSIVE FORCE EXERTED ON THE DEPTH GAUGE OR PLACING / DROPPING HEAVY INSTRUMENTS ON TOP OF THE DEVICE DURING THE STERILIZATION PROCESS COULD HAVE LED 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LONG TIP IS BROKEN OFF OF EACH OF THREE DEPTH GAUGE DEVICES. IT IS UNKNOWN WHEN THE DEVICES BROKEN AND IF THERE WAS ANY PATIENT OR PROCEDURE INVOLVEMENT. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357549 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE, DEPTH HTJ SYNTHES JENNERSVILLE 6984847

    Patients

    Seq Age Sex Outcome Treatment
    1