BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERISMA LP

    MDR report key: 5917907 · Received August 31, 2016

    Report

    Report Number
    3009962553-2016-00001
    Event Type
    Malfunction
    Date Received
    August 31, 2016
    Date of Event
    June 13, 2016
    Report Date
    June 21, 2016
    Manufacturer
    CLARIANCE SAS.
    Product Code
    HXX
    UDI-DI
    03700780623303
    PMA / PMN Number
    K153326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE COMPANY HAS DETERMINED THAT THE SUBJECT EVENT IN THIS MDR IS LIKELY NOT REPORTABLE, THE COMPANY HAS DECIDED TO FILE THIS MDR IN AN ABUNDANCE OF CAUTION AND TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803 VISUAL EXAMINATION AT THE MACROSCOPIC LEVEL REVEALED THAT THE FRACTURE WAS LOCATED AT THE DISTAL TIP OF THE SCREWDRIVER SHAFT. THE FRACTURED TIP WAS NOT PROVIDED FOR ANALYSIS. THE FRACTURE ANALYSIS REPORT SUGGESTS THAT THE DRIVER UNDERWENT A QUASI-STATIC OVERLOAD TORSIONAL SHEAR FAILURE STARTING AT THE HEX LOBES AND EXTENDING TO THE OTHERS HEX LOBES OF THE SHAFT, THE POTENTIAL FRACTURE TERMINATION SITE. 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. THE ROOT CAUSE FOR THE DISTAL TIP BREAKING CANNOT BE POSITIVELY DETERMINED. HOWEVER, THE FRACTURE ANALYSIS REPORT SUGGESTS THAT THE DRIVER UNDERWENT A QUASI-STATIC OVERLOAD TORSIONAL SHEAR FAILURE STARTING AT THE HEX LOBES AND EXTENDING TO THE OTHERS HEX LOBES OF THE SHAFT, THE POTENTIAL FRACTURE TERMINATION SITE. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CUSTOMER AND NO SYSTEMIC TRENDS REQUIRING IMMEDIATE ACTION HAVE BEEN OBSERVED

    Description of Event or Problem · 1

    THE DISTAL TIP OF SCREWDRIVER BROKE OFF WHILE INSERTING A POLYAXIAL PEDICLE SCREW IN THE LUMBAR REGION OF THE SPINE. THE BROKEN TIP HAS NOT BEEN RETRIEVED. IT IS CAPTURED IN THE SCREW INSIDE OF THE PATIENT. SURGERY WAS COMPLETED WITH NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571323 ERISMA LP SCREWDRIVER HXX CLARIANCE SAS. 18710024 G160X 03700780623303

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR