BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUFEX DIRECTOR MRR ANGLED BULLET

    MDR report key: 10469984 · Received August 31, 2020

    Report

    Report Number
    1219602-2020-01330
    Event Type
    Malfunction
    Date Received
    August 31, 2020
    Date of Event
    August 5, 2020
    Report Date
    September 30, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NBH
    UDI-DI
    00885556533314
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 71935072 ACUFEX MRR DIRECTOR BULLET INTENDED FOR USE IN TREATMENT WAS RETURNED FOR EVALUATION. THIS IS A REUSABLE INSTRUMENT. IT WAS CONFIRMED THAT A TOOTH WAS BROKEN. ANOTHER TOOTH HAD A ROLLED TIP. THE TOOTH WAS NOT FOUND. STRIATIONS MARKS WERE OBSERVED. THE BREAKAGE IS ALIGNED WITH SUBSTANTIAL FORCE, ENTANGLEMENT DURING STERILIZATION, OR CONTACT WITH ANOTHER INSTRUMENT OR DEVICE. PER IFU 81101022 ¿PRIOR TO USE, INSPECT THE DEVICE TO ENSURE IT IS NOT DAMAGED. DO NOT USE A DAMAGED DEVICE. THESE INSTRUMENTS ARE DESIGNED FOR REPEATED USE WITH PROPER CARE AND HANDLING.¿ AS WITH ANY SURGICAL INSTRUMENT, CAREFUL ATTENTION SHOULD BE EXERCISED TO ENSURE THAT EXCESSIVE FORCE IS NOT PLACED ON THE INSTRUMENT. EXCESSIVE FORCE CAN RESULT IN INSTRUMENT FAILURE. COMPLAINT HISTORY REVIEW INDICATED NO SIMILAR ALLEGATIONS FOR THE LOT NUMBER REPORTED. BATCH REVIEW DID NOT INDICATE A CONDITION, PRODUCT OR PROCEDURE FAILURE THAT SUPPORTED THE ALLEGATION. NO ROOT CAUSE RELATED TO THE MANUFACTURE OF THE DEVICE WAS CONFIRMED. THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SURGERY, THE TIP OF THE ACUFEX BROKE OFF AFTER IT WAS UNPACKED. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937333 ACUFEX DIRECTOR MRR ANGLED BULLET ACCESSORIES,ARTHROSCOPIC NBH SMITH & NEPHEW, INC. 71935072 18LTN0002C 00885556533314

    Patients

    Seq Age Sex Outcome Treatment
    1