BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 6270114 · Received January 23, 2017

    Report

    Report Number
    2530088-2017-10026
    Event Type
    Malfunction
    Date Received
    January 23, 2017
    Report Date
    January 5, 2017
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HTJ
    UDI-DI
    10886982189943
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT DEVELOPMENT INVESTIGATION HAS BEEN COMPLETED FOR PART# 319.006, LOT# 4060383. A DEVICE HISTORY RECORD (DHR) REVIEW, VISUAL INSPECTION, FUNCTIONAL TEST, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE COMPLAINT CONDITION IS CONFIRMED AS THE DEPTH GAGE WAS RECEIVED WITH THE BODY COMPONENT (319.006.4) SHOWING SLIGHT RESISTANCE AGAINST THE CALIBRATED SLIDER COMPONENT DURING USE. HOWEVER, THIS HAS NOT IMPAIRED THE FUNCTION OF THE DEVICE. THE BODY COMPONENT CAN STILL BE MOVED THROUGH ITS FULL RANGE OF MOTION BY HAND WITH LIGHT FORCE. THE BALANCE OF THE DEVICE IS IN FUNCTIONAL CONDITION. THUS, THE COMPLAINT CONDITION IS CONFIRMED, CONSISTENT WITH THE REPORTED CONDITION, AND CAN BE REPLICATED. IT WAS OBSERVED THAT THE RETURNED PROTECTION SLEEVE IS NOT THE ORIGINAL PROTECTION SLEEVE FOR PART NUMBER 319.006. THE RETURNED PART IS CONFORMING TO COMPONENT 319.06.8 PER DRAWING. THUS, IT IS LIKELY FROM PART NUMBER 319.06. THE DEVICE WAS INSPECTED AND NO ISSUES WERE OBSERVED. THERE IS NO EVIDENCE THAT THIS DEVICE CONTRIBUTED TO THE COMPLAINT CONDITION, AND THEREFORE NO ADDITIONAL INVESTIGATION WILL BE PERFORMED ON THIS DEVICE. THIS DEPTH GAUGE IS USED FOR MEASURING 2.0MM AND 2.4MM SCREWS IN VARIOUS TRAUMA (INCLUDING VETERINARY) PLATING SYSTEMS. IT IS LISTED IN TECHNIQUES GUIDES FOR THE DISTAL RADIUS, DISTAL ULNA, ELBOW SYSTEM, FOREFOOT/MIDFOOT, DISTAL FIBULA, DISTAL HUMERUS, CLAVICLE, ROTATION CORRECTION PLATE SYSTEM AND VET MINI FRAGMENT SYSTEM. RELEVANT DRAWINGS WERE REVIEWED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. ALTHOUGH THE EXACT CAUSE CANNOT BE DETERMINED, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS WEAR FROM USE AND REPEATED STERILIZATION CYCLES OVER THE LIFE OF THE DEVICE. 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

    NO PATIENT INVOLVEMENT REPORTED. DATE OF EVENT IS UNKNOWN. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 319.006, LOT# 4060383. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: JUN 18, 2014. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. 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. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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 A SYNTHES DEPTH GAUGE WAS NOT OPERATING AS INTENDED, AS THE SLIDE IS "ROUGH AND STICKING" WHEN USED. THE ISSUE WAS DISCOVERED OUTSIDE OF THE OPERATING ROOM BY STERILE PROCESSING AND THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53108 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE, DEPTH HTJ SYNTHES BRANDYWINE 4060383 10886982189943

    Patients

    Seq Age Sex Outcome Treatment
    1