BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 4102739 · Received September 19, 2014

    Report

    Report Number
    3003787298-2014-10044
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    SYNTHES JENNERSVILLE
    Product Code
    HTJ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: EVENT DATE: SHOULD BE (B)(6) 2014. 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: 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. THE DEVICE HISTORY RECORD WAS REVIEWED AND 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AS PART OF THE PRODUCT INVESTIGATION REPORTED 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 DEPTH GAUGE WAS RECEIVED ASSEMBLED. ONE DEPTH GAUGE (PART# 319.006) WAS RETURNED WITH COMPLAINT CATEGORY OF ¿BROKEN¿. 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. THE INFORMATION IS PROVIDED PER THE 2.4 MM VARIABLE ANGLE LCP DISTAL RADIUS SYSTEM TECHNIQUE GUIDE J8301-I. THE RETURNED DEPTH GAUGE (LOT# 6993093) WAS MANUFACTURED ON JULY, 2012 AND IS 2 YEARS OLD. THE DEPTH GAUGE WAS RECEIVED ASSEMBLED. 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 DOES NOT FALL OFF WHEN THE DEVICE IS HELD VERTICALLY. THE MINIATURE BALL ON THE SLIDER IS PRESENT. THERE ARE MULTIPLE NICKS AND SCRATCHES ON THE DEVICE CONSISTENT WITH NORMAL USE. ALSO, THE PROTECTION SLEEVE WAS NOT RETURNED WITH THE DEVICE. AS NOTED IN PRIOR COMPLAINTS, 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 (PART#319.006.03 REVISION E) 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 PART WAS MANUFACTURED TO DRAWING (319_006 REVISION F). THE DIMENSIONS, MATERIAL, AND TOLERANCES ARE WITHIN SPECIFICATION. THE COMPLAINT IS CONFIRMED FOR THE COMPLAINT CONDITION. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 ON (B)(6) 2014 THAT THE METAL PORTION OF THE DEPTH GAUGE BROKE OFF WHILE FIELD EQUIPMENT SET WAS BEING ORGANIZING IN THE STORAGE CENTER. THERE WAS NO PATIENT INVOLVEMENT. THERE HAD BEEN NO PRIOR ISSUES WITH THE DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584991 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE, DEPTH HTJ SYNTHES JENNERSVILLE 6993093

    Patients

    Seq Age Sex Outcome Treatment
    1