BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 5520740 · Received March 23, 2016

    Report

    Report Number
    1719045-2016-10249
    Event Type
    Malfunction
    Date Received
    March 23, 2016
    Report Date
    March 8, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTJ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: AUGUST 21, 2014. PART 319.006, LOT 7771007: NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE 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

    PRODUCT INVESTIGATION SUMMARY: ONE (1) OF THE FOLLOWING WAS RECEIVED: DEPTH GAUGE (PART 319.006 / LOT 7771007). THE RETURNED DEPTH GAUGE 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 FOURTEEN (14) TECHNIQUE GUIDES INCLUDING: 2.4 MM VARIABLE ANGLE LCP DISTAL RADIUS SYSTEM (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. 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. THE RELEVANT DRAWING FOR THE DEVICE(S) WAS REVIEWED. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. 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. 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. ALTHOUGH THE EXACT CAUSE CANNOT BE DETERMINED, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS EXCESSIVE FORCE EXERTED ON THE DEPTH GAUGE BY PLACING / DROPPING HEAVY INSTRUMENTS ON TOP OF THE DEVICE DURING THE STERILIZATION PROCESS. 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 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. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A SERVICE HISTORY RECORD REVIEW WAS ATTEMPTED FOR THE SUBJECT DEVICE LOT. THE REVIEW COULD NOT BE COMPLETED BECAUSE THE DEVICE IS A LOT-CONTROLLED ITEM. THE MANUFACTURE DATE IS AUG 21, 2014. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. A SERVICE AND REPAIR EVALUATION WAS PERFORMED FOR THE SUBJECT DEVICE. THE REPAIR TECHNICIAN REPORTED ¿TIP BROKEN¿ AS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE SERVICE AND REPAIR EVALUATION WAS CONFIRMED. THE ITEM WILL BE FORWARDED TO SYNTHES CUSTOMER QUALITY FOR ADDITIONAL INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS ALSO REQUESTED. THE ADDITIONAL INVESTIGATION RESULTS ARE PENDING COMPLETION. 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 SILVER TIP OF THE DEPTH GAUGE WAS BROKEN POSTOPERATIVELY AFTER AN UNKNOWN VETERINARY PROCEDURE. IT WAS REPORTED THAT THERE WAS NO ANIMAL PATIENT IN THE OPERATING ROOM WHEN THE BREAKAGE OCCURRED. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174810 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE, DEPTH HTJ SYNTHES MONUMENT 7771007

    Patients

    Seq Age Sex Outcome Treatment
    1