BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS

    MDR report key: 3830572 · Received May 23, 2014

    Report

    Report Number
    3003787298-2014-10022
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Report Date
    May 6, 2014
    Manufacturer
    SYNTHES JENNERSVILLE
    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

    A PD EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE ONE DEPTH GAUGE (PART # 319.004) WAS RETURNED WITH COMPLAINT CATEGORY OF ¿DOES NOT FUNCTION.¿ THE DEPTH GAUGE IS PART OF 1.5 MM LCP MODULAR MINI FRAGMENT SYSTEM AND IS USED TO MEASURE THE DEPTH OF THE HOLES FOR THE 1.3 MM/1.5 MM SCREWS TO ENSURE THE CORRECT SCREW LENGTH IS USED DURING THE PROCEDURE. THE INFORMATION IS PROVIDED PER THE 1.5 MM LCP MODULAR MINI FRAGMENT SYSTEM TECHNIQUE GUIDE (B)(4). THE RETURNED DEPTH GAUGE (LOT # 6805184) WAS MANUFACTURED ON NOVEMBER, 2011 AND IS APPROXIMATELY 3 YEARS OLD. THE DEPTH GAUGE WAS RECEIVED ASSEMBLED. THE DISTAL TIP (NEEDLE) IS BENT AND KINKED IN SEVERAL PLACES. ALSO, THE PROTECTION SLEEVE WAS NOT RETURNED WITH THE DEPTH GAUGE. THERE ARE MULTIPLE NICKS AND SCRATCHES ON THE DEVICE CONSISTENT WITH NORMAL USE. THE THICKNESS OF THE NEEDLE (1.0 MM) IS DRIVEN BY THE FACT THAT THE NEEDLE MUST FIT INTO A DRILLED HOLE FOR THE 1.3 MM SCREWS, AND THE LENGTH (54 MM) IS DETERMINED SO THE SLIDER CAN MEASURE SCREWS FOR BOTH THE 1.3 MM AND 1.5 MM SYSTEMS. THE MATERIAL OF THE NEEDLE PROBE COMPONENT (PART #319.004.03 REVISION (B)(4)) IS EXTRA HARD (B)(4), WHICH IS AN APPROPRIATE MATERIAL FOR AN INSTRUMENT COMPONENT OF THIS TYPE. A REVIEW OF THE DESIGN DRAWING INDICATES THAT THE RETURNED PART WAS MANUFACTURED TO DRAWING ((B)(4)). 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 OR USE 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.

    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 REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED: NO ISSUES WERE FOUND DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THE 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 THE DEPTH GAUGE DOES NOT SLIDE ANYMORE. THE DEVICE WAS DISCOVERED DURING THE ROUTINE CHECK OF FIELD EQUIPMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308346 DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS GAUGE, DEPTH HTJ SYNTHES JENNERSVILLE 6805184

    Patients

    Seq Age Sex Outcome Treatment
    1