BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 5591016 · Received April 20, 2016

    Report

    Report Number
    2530088-2016-10111
    Event Type
    Malfunction
    Date Received
    April 20, 2016
    Report Date
    April 4, 2016
    Manufacturer
    SYNTHES BRANDYWINE
    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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE PREVIOUSLY REPORTED PRODUCT INVESTIGATION WAS COMPLETED FOR DEPTH GAUGE, PART 319.006, LOT 4911457, NOT LOT 7440447. THE INVESTIGATION RESULTS WERE CORRECTLY REPORTED IN THE PREVIOUSLY FOLLOW UP REPORT (B)(4). 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: PART NUMBER: 319.006 , SYNTHES LOT NUMBER: 4911457: RELEASE TO WAREHOUSE DATE: JANUARY 04, 2005. MFG SITE: (B)(4). A MATERIAL REVIEW REPORT WAS GENERATED DURING PRODUCTION FOR A PRESS FIT FEATURE NOT CONFORMING. THE FEATURE IS FOR PRESS FIT AT ASSEMBLY, THE HOLE WILL BE REAMED WHEN ASSEMBLED. RELEVANCE TO COMPLAINT CONDITION CANNOT BE DETERMINED UNTIL THE PRODUCT IS RETURNED FOR INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE ARE POTENTIAL ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS PART NUMBER 319.006 WITH LOT NUMBER(S) 4911457 IS A LOT/BATCH CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS JANUARY 04, 2005. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    A PRODUCT INVESTIGATION WAS COMPLETED: ONE DEPTH GAUGE (PART 319.006, LOT 7440447) WAS RECEIVED FOR EVALUATION. THE DEVICE SHOWS REGULAR USE DURING ITS LIFESPAN. THE HOOKED NEEDLE STEM OF THE DEVICE IS BROKEN OFF AT THE BASE OF THE BLACK BODY (THE BROKEN STEM IS APPROXIMATELY 75MM IN LENGTH) AND WAS RETURNED. THIS PARTICULAR DEPTH GAUGE IS PART OF AT LEAST 14 TECHNIQUE GUIDES, INCLUDING THE 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. ALTHOUGH THE DAMAGE APPEARS TO BE THE RESULT OF EXCESSIVE WEIGHT BEING PLACED ONTO THE NEEDLE DURING STERILE PROCESSING AND DOES NOT APPEAR TO BE THE RESULT OF NORMAL USE; THE EXACT CAUSE COULD NOT BE IDENTIFIED. THIS COMPLAINT IS CONFIRMED. SERVICE AND REPAIR EVALUATION: THE DEVICE WAS RECEIVED BY SERVICE AND REPAIR, AND THE BROKEN COMPONENT WAS CONFIRMED. DEVICE WAS UNABLE TO BE REPAIRED AND WAS SENT TO CUSTOMER QUALITY (CQ). A SERVICE HISTORY REVIEW WAS UNABLE TO BE PERFORMED SINCE THIS IS A LOT/BATCH CONTROLLED DEVICE. THE RELEVANT DRAWINGS FOR THE DEVICE(S) WERE REVIEWED. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO MANUFACTURING OR DESIGN ISSUES WERE NOTED DURING THE INVESTIGATION. THE DESIGN IS DETERMINED TO BE ADEQUATE FOR ITS INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED. 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 A DEPTH GAUGE TIP HAD BROKEN OFF. THE DEVICE WAS DISCOVERED IN THE CENTRAL PROCESSING DEPARTED; THERE WAS REPORTEDLY NO OPERATIVE EVENT INVOLVED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244414 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE, DEPTH HTJ SYNTHES BRANDYWINE 4911457

    Patients

    Seq Age Sex Outcome Treatment
    1