BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALL TIP FEELER (CURVER)

    MDR report key: 6212525 · Received December 29, 2016

    Report

    Report Number
    1526439-2016-10949
    Event Type
    Malfunction
    Date Received
    December 29, 2016
    Date of Event
    December 5, 2016
    Report Date
    December 5, 2016
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    HXB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE (1) BALL TIP FEELER ¿ CURVED [PRODUCT CODE: 2750-10-160, LOT NO: TY19468] WAS RETURNED TO THE COMPLAINTS HANDLING UNIT (CHU) FOR EVALUATION. VISUAL EXAMINATION AT THE MACROSCOPIC LEVEL REVEALED THAT THE FRACTURE WAS LOCATED AT THE CONNECTION BETWEEN THE HANDLE AND THE FEELER TIP. THE FRACTURE ANALYSIS REPORT SHOWS EVIDENCE OF PLASTIC DEFORMATION AND A ROUGH APPEARANCE ACROSS BOTH SHAFT SURFACES IN ADDITION TO BROKEN WELDS ALONG THE OUTSIDE OF THE SHAFT. THE FEELER ALSO EXHIBITED PLASTIC BENDING DEFORMATION OF THE WELD MATERIAL CONSISTENT WITH THE APPLICATION OF A CANTILEVER LOAD. THESE CHARACTERISTICS INDICATE THAT THE FEELER UNDERWENT A STATIC OVERLOAD FAILURE. NO MATERIAL DEFECTS OR OTHER ABNORMALITIES WERE OBSERVED IN THIS ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. NO EMERGING TRENDS WERE FOUND REQUIRING FURTHER ACTIONS. A DEFINITIVE ROOT CAUSE FOR THE BALL TIP FEELER SHAFT BREAKING CANNOT BE POSITIVELY DETERMINED. HOWEVER, THE FRACTURE ANALYSIS REPORT INDICATES THAT THE FEELER UNDERWENT A STATIC OVERLOAD FAILURE. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS REQUIRING IMMEDIATE ACTION HAVE BEEN OBSERVED, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. 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

    (B)(4). A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. 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

    THIS ITEM WAS BEING SHIPPED BACK FROM SURGERY AND ARRIVED WITH BOX BROKE AND THE BALL TIP FEELER WAS BROKEN OFF IN THE PKG AND UNUSABLE. I WILL NEED THIS BALL TIP FEELER REPLACED AS IT DOES NOT SEEM FIT TO BE USED IN SURGERY IN THE FUTURE. PART#275010160X 1

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864426 BALL TIP FEELER (CURVER) PROBE HXB DEPUY SYNTHES SPINE TY19468

    Patients

    Seq Age Sex Outcome Treatment
    1