BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S4C ROD BENDING FORCEPS F/3.5MM RODS

    MDR report key: 11602943 · Received April 1, 2021

    Report

    Report Number
    9610612-2021-00279
    Event Type
    Malfunction
    Date Received
    April 1, 2021
    Date of Event
    March 11, 2021
    Report Date
    July 20, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    HXW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS NO INDICATION FOR A MATERIAL, MANUFACTURING OR DESIGN-RELATED FAILURE. BASED UPON NEW INFORMATION RECEIVED, THIS EVENT WAS RE-EVALUATED AND IS CONSIDERED NO LONGER REPORTABLE. NO MALFUNCTION OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FW037R - S4C ROD BENDING FORCEPS F/3.5MM RODS. ACCORDING TO THE COMPLAINT DESCRIPTION, THE SCREW LOOSENED DURING SURGERY. DOCTOR TRIED TO ALTER THE BEND CONTOUR WITH THE WHEEL ON THE INSTRUMENT THE SETTING WOULD NOT HOLD DUE TO THE LOOSE SCREW THAT HOLDS THE WHEEL IN PLACE. WE TRIED TIGHTENING THIS SCREW HOWEVER IT CONTINUED TO FREELY SPIN. THERE WAS A 5 MINUTE DELAY TO THE PROCEDURE AND NO HARM DONE TO THE PATIENT. THIS MALFUNCTION PROLONGED THE SURGERY FOR 5 MINUTES. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501215 S4C ROD BENDING FORCEPS F/3.5MM RODS SPINE SURGERY HXW AESCULAP AG FW037R

    Patients

    Seq Age Sex Outcome Treatment
    1