BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMR - EXPANSION EXTRACTOR

    MDR report key: 11789067 · Received May 7, 2021

    Report

    Report Number
    3008021110-2021-00035
    Event Type
    Malfunction
    Date Received
    May 7, 2021
    Date of Event
    April 28, 2021
    Report Date
    September 16, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWT
    PMA / PMN Number
    K100858
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BY CHECKING THE DHR OF THE LOT NUMBER: 18AQ1G4, NO PRE-EXISTING ANOMALIES WERE DETECTED ON THE PIECES MANUFACTURED WITH THIS LOT NUMBER. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT NUMBER. THE INSTRUMENT WAS NOT AVAILABLE TO BE RETURNED FOR INSPECTION. THEREFORE, BASED ON THE VERY FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE EVENT. HOWEVER, CONSIDERING THAT: CHECKING THE MANUFACTURING CHARTS OF THE LOT NUMBER INVOLVED IN THE EVENT, NO PRE-EXISTING ANOMALY WAS FOUND OUT. WE HAVE NO EVIDENCE TO CONSIDER THE EVENT AS PRODUCT RELATED. PMS DATA: ACCORDING TO THE RELEVANT PMS DATA, WE CAN ESTIMATE THE OCCURRENCE RATE OF MALFUNCTIONING OF THE SMR - EXPANSION ESTRACTOR (PART CODE 9013.52.165) TO BE AROUND (B)(4) WORLDWIDE. PLEASE NOTE THAT THIS OCCURRENCE RATE IS OVERESTIMATED BECAUSE IT DOES NOT CONSIDER THE REUSE OF THE INSTRUMENTS BUT ONLY THE TOTAL NUMBER OF PIECES MANUFACTURED. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A FINAL MDR.

    Description of Event or Problem · 0

    DURING SHOULDER SURGERY PERFORMED ON (B)(6) 2021, THE STEM FROM THE PROXIMAL HUMERAL BODY WAS GOING TO BE EXTRACTED BUT THE SMR - EXPANSION EXTRACTOR (PART CODE: 9013.52.165, LOT NUMBER: 18AQ1G4) WOULD NOT FIT FAR ENOUGH ON TO EXTRACT OFF. SURGERY WAS PROLONGED OF 20 MINUTES. EVENT HAPPENED IN THE UNITED STATES.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHR OF THE LOT #18AQ1G4, NO PRE-EXISTING ANOMALIES WERE DETECTED ON THE PIECES MANUFACTURED WITH THIS LOT #. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT#. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    DURING SHOULDER SURGERY PERFORMED ON (B)(6) 2021, THE STEM FROM THE PROXIMAL HUMERAL BODY WAS GOING TO BE EXTRACTED BUT THE SMR - EXPANSION EXTRACTOR (PRODUCT CODE 9013.52.165, LOT# 18AQ1G4) WOULD NOT FIT FAR ENOUGH ON TO EXTRACT OFF. SURGERY WAS PROLONGED OF 20 MINUTES. EVENT HAPPENED IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691248 SMR - EXPANSION EXTRACTOR EXPANSION EXTRACTOR KWT LIMACORPORATE S.P.A. 9013.52.165 18AQ1G4

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other