BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLENOID REAMER SMALL

    MDR report key: 6173192 · Received December 14, 2016

    Report

    Report Number
    3008021110-2016-00050
    Event Type
    Malfunction
    Date Received
    December 14, 2016
    Date of Event
    May 23, 2016
    Report Date
    October 20, 2017
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWT
    PMA / PMN Number
    K100858
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CHECK OF THE DHR OF THE LOT # INVOLVED (14AA342) SHOWED NO DIMENSIONAL / FUNCTIONAL ANOMALIES ON THE (B)(4) PIECES PLACED ON THE MARKET WITH THIS LOT #. WE WILL SUBMIT A FINAL MDR AFTER COMPLETING THE INVESTIGATION ON THIS CASE.

    Additional Manufacturer Narrative · 1

    THE CHECK OF THE DHR OF THE LOT # INVOLVED (14AA342) SHOWED NO DIMENSIONAL / FUNCTIONAL ANOMALIES ON THE 54 PIECES PLACED ON THE MARKET WITH THIS LOT #. THE INVOLVED INSTRUMENT WAS RECEIVED BY LIMACORPORATE. VISUAL ANALYSIS OF THE REAMER CONFIRMED THAT THE REAMER CUTTING EDGE IS BLUNT. A TECHNICAL ANALYSIS OF THE DEVICE HIGHLIGHTED THAT THE CUTTING EDGE WAS BEAD BLASTED AND CHROME COATING WAS APPLIED ON IT. BEAD BLASTING AND CHROME COATING APPLIED TO THE CUTTING EDGE REDUCE THE EDGE SHARPNESS AND THE REAMER RESULTS BLUNT. IN SEPTEMBER 2015, BEFORE RECEIVING THIS COMPLAINT, LIMACORPORATE UPDATED THE TECHNICAL DRAWINGS OF THE REAMERS TO SPECIFY THAT BEAD BLASTING AND CHROME COATING MUST NOT BE APPLIED ON THE CUTTING EDGE OF THE REAMERS WITH PRODUCT CODE 9013.75.160-165-170. THE REAMER INVOLVED IN THIS COMPLAINT WAS MANUFACTURED IN 2014, BEFORE INTRODUCTION OF THIS NOTE IN THE TECHNICAL DRAWING. PMS DATA: A TOTAL OF 5 SIMILAR CASES HAVE BEEN REPORTED TO LIMACORPORATE ON BLUNT GLENOID REAMERS WITH PRODUCT CODES 9013.75.160-165-170 ON A TOTAL OF (B)(4) REAMERS MANUFACTURED. NO CORRECTIVE ACTION PLANNED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET IN ORDER TO PROMPTLY DETECT ANY SIMILAR ISSUE.

    Description of Event or Problem · 1

    INTRA-OPERATIVE ISSUE INVOLVING A SMALL SMR-GLENOID REAMER (MODEL # 9013.75.160, LOT # 14AA342). SURGEON WAS USING THE SMALL REAMER WHEN HE NOTICED THAT IT WAS BLUNT. THE REAMER WAS ATTACHED TO DRILL AT THE TIME OF SURGERY. MINIMAL EXTENSION OF SURGICAL TIME (3 MINUTES). THE SURGERY WAS SUCCESSFULLY COMPLETED BY THE SURGEON USING A STANDARD REAMER. NO ADVERSE EFFECT ON PATIENT. EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    INTRA-OPERATIVE ISSUE INVOLVING A SMALL SMR-GLENOID REAMER (MODEL # 9013.75.160, LOT # 14AA342). SURGEON WAS USING THE SMALL REAMER WHEN HE NOTICED THAT IT WAS BLUNT. THE REAMER WAS ATTACHED TO DRILL AT THE TIME OF SURGERY. MINIMAL EXTENSION OF SURGICAL TIME (3 MINUTES). THE SURGERY WAS SUCCESSFULLY COMPLETED BY THE SURGEON USING A STANDARD REAMER. NO ADVERSE EFFECT ON PATIENT. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825218 GLENOID REAMER SMALL GLENOID REAMER SMALL KWT LIMACORPORATE S.P.A. 9013.75.160 2014AA342

    Patients

    Seq Age Sex Outcome Treatment
    1