BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 3931169 · Received July 14, 2014

    Report

    Report Number
    2530088-2014-10183
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Report Date
    June 19, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HTJ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. COMPLAINT DETERMINED TO BE A REPORTABLE MALFUNCTION BY SYNTHES CLINICIAN ON (B)(4) 2014 BASED ON THE PRODUCT INVESTIGATION REPORT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). THE DEVICE HISTORY REVIEW(DHR) WAS REVIEWED AND MANUFACTURING REVIEW REPORT (MRR) #(B)(4) WAS FOUND ON P/N 319.006.04 LOT #4949478 FOR F1 WORSE THAN N5. THE PARTS WERE RETURNED TO THE SUPPLIER, REWORKED INSPECTED AND PASSED. THIS NONCONFORMANCE IS NOT RELEVANT TO THE COMPLAINT BECAUSE THE ISSUE ON THE FINISH ON THE BODY COMPONENT NOT THE MEASURING NEEDLE. MRR #(B)(4) WAS FOUND ON P/N 319.006.01 LOT #4905465 FOR SCRATCH ON 1 PART OUT OF (B)(4) SUPPLIER PARTS. THE ONE NONCONFORMING PART WAS SCRAPPED. THIS NONCONFORMANCE IS NOT RELEVANT TO THE COMPLAINT BECAUSE THE ISSUE IS VISUAL ON THE SLEEVE COMPONENT NOT THE MEASURING NEEDLE. MRR #(B)(4) WAS FOUND ON P/N 319.006.03 LOT #4872871 FOR T1 FAILED GO GAGE AND OVERLAY ON SUPPLIER PARTS. THE PARTS WERE RETURNED TO THE SUPPLIER, REWORKED, INSPECTED AND PASSED. THE RELEVANCE OF THIS NONCONFORMANCE IS NOT ABLE TO BE DETERMINED AT THIS TIME. THE VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AS PART OF THE PRODUCT INVESTIGATION REPORTED 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 IS NO RESISTANCE BETWEEN THE BODY AND THE SLIDER. 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 (B)(4). THE RETURNED DEPTH GAUGE (LOT# 5070323) WAS MANUFACTURED ON SEPTEMBER, 2005 AND IS APPROXIMATELY 9 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 IS NO RESISTANCE BETWEEN THE BODY AND THE SLIDER. THE OUTER BODY OF THE DEPTH GAUGE FALLS OFF WHEN THE DEVICE IS HELD VERTICALLY. THE MINIATURE BALL ON THE SLIDER IS MISSING. THERE ARE MULTIPLE NICKS AND SCRATCHES ON THE DEVICE CONSISTENT WITH NORMAL USE. 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 ((B)(4)). SINCE THEN THERE WAS ONE UPDATE TO THE DESIGN THAT DID NOT AFFECT THE INTENDED USAGE OF THE DEVICE. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE MEASURING NEEDLE ON THE DEPTH GAUGE WAS BROKEN OR MISSING. NO REPORTED PATIENT OR PROCEDURE HARM NOTED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410785 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE, DEPTH HTJ SYNTHES BRANDYWINE 5070323

    Patients

    Seq Age Sex Outcome Treatment
    1