BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.7MM & SMALL SCREWS

    MDR report key: 6477202 · Received April 10, 2017

    Report

    Report Number
    2530088-2017-10086
    Event Type
    Malfunction
    Date Received
    April 10, 2017
    Report Date
    March 21, 2017
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HTJ
    UDI-DI
    10886982189950
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INVOLVEMENT WAS REPORTED. DATE OF EVENT IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 319.01, LOT# 5193124. MANUFACTURING LOCATION: (B)(6), RELEASE TO WAREHOUSE DATE: (B)(6) 2006. 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. 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 DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE. THE 319.01 LOT NUMBER 5193124 DEPTH GAUGE WAS RETURNED AND REPORTED TO HAVE BEEN CATCHING WHILE MEASURING. THIS COMPLAINT CONDITION WAS LIKELY CAUSED BY OVER ELEVEN YEARS OF CONSISTENT USE AND POSSIBLE ROUGH HANDLING DURING SURGERY OR STERILE PROCESSING; HOWEVER, THIS COMPLAINT IS NOT LIKELY A RESULT OF ANY DESIGN OR MANUFACTURING RELATED DEFICIENCY. A VISUAL INSPECTION AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THIS COMPLAINT IS CONFIRMED. NO NEW MALFUNCTIONS WERE OBSERVED DURING THE COURSE OF THIS INVESTIGATION. THE 319.01 DEPTH GAUGE IS AN INSTRUMENT ROUTINELY USED IN 2.4MM LCP DISTAL RADIUS SYSTEM (TECHNIQUE GUIDE). THE DEVICE WAS RETURNED AND REPORTED TO HAVE BEEN CATCHING WHILE MEASURING. THIS CONDITION IS CONFIRMED; THE MEASURING WIRE IS SLIGHTLY BENT CAUSING THE TIP TO CATCH ON THE DISTAL PORTION OF THE BODY OF THE DEPTH GAUGE. THE DEVICE WAS MANUFACTURED IN 3/2006 AND IS OVER ELEVEN YEARS OLD. THE BALANCE OF THE RETURNED DEVICE IS IN FAIRLY WORN CONDITION WITH SOME MARKINGS AND SUPERFICIAL WEAR ALONG ITS LENGTH. DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. THE CONDITION OF THE RETURNED DEVICE DOES AGREE WITH THE COMPLAINT DESCRIPTION. WHETHER THE COMPLAINT CONDITION FOR THIS DEVICE CAN BE REPLICATED IS NOT APPLICABLE FOR THIS CONDITION. ALL MEASUREMENTS HAVE BEEN PERFORMED BY CALIPERS. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE 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 THAT WHILE THE SALES CONSULTANT WAS REVIEWING HIS FIELD EQUIPMENT LOCKING COMPRESSION PLATE (LCP) SMALL FRAGMENT SET, HE NOTED THAT THE DEPTH GAUGE FOR SMALL SCREWS WAS CATCHING INSIDE WHEN GLIDING FOR MEASUREMENT. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.7MM & SMALL SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258386 DEPTH GAUGE FOR 2.7MM & SMALL SCREWS GAUGE,DEPTH HTJ SYNTHES BRANDYWINE 5193124 10886982189950

    Patients

    Seq Age Sex Outcome Treatment
    1