BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAMERS AND DRILLS SHAFT

    MDR report key: 6986501 · Received October 30, 2017

    Report

    Report Number
    3008021110-2017-00096
    Event Type
    Malfunction
    Date Received
    October 30, 2017
    Date of Event
    September 22, 2017
    Report Date
    May 14, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWT
    PMA / PMN Number
    K100858
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION BY CHECKING THE DHR OF THE LOT NUMBER INVOLVED, NO ANOMALIES HAVE BEEN DETECTED ON A TOTAL OF 22 SMR DRILLS SHAFT MANUFACTURED WITH THE SAME LOT NUMBER (15AA521). NO OTHER COMPLAINTS REPORTED ON THE SAME LOT NUMBER. INSTRUMENT ANALYSIS THE INSTRUMENT WAS RETURNED TO THE MANUFACTURED AND WAS ANALYZED INTERNALLY. THE VISUAL INSPECTION LED TO THE CONCLUSION THAT THE INSTRUMENT, DURING ROTATION (PERFORMED WITH A POWER TOOL, ACCORDING TO THE TRACE VISIBLE ON THE INSTRUMENT), GOT STUCK AND BROKE DUE TO THE TORQUE FORCE APPLIED, WHICH DEFORMED THE OUTER GUIDE. ACCORDING TO THE SURGICAL TECHNIQUE, THE GLENOID REAMER OF THE PROPER SIZE (SMALL, STD OR LARGE) HAS TO BE CONNECTED TO THE SMR GLENOID REAMERS AND DRILLS AND THE GLENOID SURFACE SHOULD BE REAMED CAREFULLY, IN ORDER TO REMOVE THE CARTILAGE AND EXPOSE THE SUBCHONDRAL BONE RATHER THAN EXCESSIVE BONE REMOVAL. THEREFORE, CONSIDERING THAT: - THE CHECK OF MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE TOTAL NUMBER OF COMPONENTS MANUFACTURED WITH LOT NUMBER 15AA521. - ACCORDING TO THE INTERNAL INVESTIGATION, THE INSTRUMENT GOT STUCK DURING REAMING AND THE TORQUE FORCE APPLIED LED TO THE BREAKAGE. WE CAN CONCLUDE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA ACCORDING TO OUR PMS DATA, WE CAN ESTIMATE THE BREAKAGE RATE OF THE INSTRUMENT SMR GLENOID REAMERS AND DRILLS TO BE (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. NO CORRECTIVE ACTIONS ARE 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 A SURGERY PERFORMED ON (B)(6) 2017, AN INTRA-OPERATIVE BREAKAGE OF SMR GLENOID REAMERS AND DRILLS (PART CODE 9013.75.350, LOT NUMBER 15AA521) OCCURRED DURING THE REAMING PROCESS. ACCORDING TO THE INFORMATION REPORTED, NEITHER EXTENSION IN SURGERY TIME NOR ADVERSE EFFECT FOR THE PATIENT. SURGEON WAS ABLE TO CONCLUDE SUCCESSFULLY THE SURGERY EVEN IF, BECAUSE OF PATIENT'S LARGE MUSCULAR STRUCTURES, DIFFICULTY WITH GLENOID EXPOSURE WAS EXPERIENCED. ESTIMATED NUMBER OF USES OF THE INSTRUMENT: APPROXIMATELY 75 USES. EVENT HAPPENED IN THE UNITED STATES.

    Additional Manufacturer Narrative · 1

    NO ANOMALIES DETECTED BY CHECKING THE DHR OF THE LOT# INVOLVED ON A TOTAL OF (B)(4) SMR DRILLS SHAFT MANUFACTURED WITH THE SAME LOT # (15AA521). NO OTHER COMPLAINTS REPORTED ON THE SAME LOT#. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    INTRA-OPERATIVE BREAKAGE OF DRILL SHAFT (MODEL# 9013.75.350, LOT# 15AA521) DURING THE REAMING PROCESS. ACCORDING TO THE INFO REPORTED, NOR EXTENSION IN SURGERY TIME NEITHER ADVERSE EFFECTS FOR THE PATIENT. SURGEON WAS ABLE TO CONCLUDE SUCCESSFULLY THE SURGERY EVEN IF, BECAUSE OF PATIENT'S LARGE MUSCULAR STRUCTURES, DIFFICULTY WITH GLENOID EXPOSURE WAS EXPERIENCED. ESTIMATED NUMBER OF USES OF THE INSTRUMENT: APPROXIMATELY 75 USES. EVENT HAPPENED IN U.S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766453 REAMERS AND DRILLS SHAFT REAMERS AND DRILLS SHAFT KWT LIMACORPORATE S.P.A. 9013.75.350 15AA521

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other