BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMR - GUIDE FOR CONICAL REAMER

    MDR report key: 12007726 · Received June 16, 2021

    Report

    Report Number
    3008021110-2021-00044
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Date of Event
    May 24, 2021
    Report Date
    November 16, 2021
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    PMA / PMN Number
    K110598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BY CHECKING THE MANUFACTURING CHARTS OF LOT#: 15AA115, NO ANOMALIES WERE DETECTED ON THE (B)(4) INSTRUMENTS PLACED ON THE MARKET WITH THE SAME LOT#. THE INSTRUMENT HAD BEEN RECEIVED BY LIMACORPORATE FOR FURTHER ANALYSIS. ANALYSIS OF INSTRUMENT: VISUAL INSPECTION CONFIRMED THE BREAKAGE OF GUIDE'S TIP. THE BREAKAGE OF THE INSTRUMENT OCCURRED AT ITS POINT OF MINIMUM SECTION. CONSIDERING THAT: CHECK OF MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE TOTAL NUMBER OF INSTRUMENTS MANUFACTURED WITH LOT#: 15AA115; THE INSTRUMENT WAS MANUFACTURED IN 2015 AND THE BREAKAGE OCCURRED IN MAY 2021; THE EXACT NUMBER OF USES IS NOT KNOWN, HOWEVER IT SHOULD BE CONSIDERED IT IS A REUSABLE TOOL AND IT WAS PLACED ON THE MARKET 6 YEARS AGO; NO DEFINITIVE CONCLUSION CAN BE DETERMINED ON THE CAUSES OF THE INSTRUMENT BREAKAGE, HOWEVER WE CAN SPECULATE THAT REPEATED USES OF THE INSTRUMENT OVER TIME TOGETHER WITH REPEATED STRESSES AND VIBRATIONS MIGHT HAVE LED TO WEAR, AND CONSEQUENTLY CAUSED THE BREAKAGE OF THE GUIDE'S NARROW TIP. PMS DATA: ACCORDING TO OUR PMS DATA, THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THE INTRA-OPERATIVE BREAKAGE OF THE GUIDE 9013.52.116. NO SPECIFIC CORRECTIVE ACTION FOR THIS CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FUTURE SIMILAR ISSUE. NOTE: THIS IS A FINAL MDR.

    Description of Event or Problem · 0

    DURING SHOULDER SURGERY PERFORMED ON (B)(6) 2021, THE NARROW TIP OF THE SMR - GUIDE FOR CONICAL REAMER (PRODUCT CODE: 9013.52.116, LOT#: 15AA115) SNAPPED OFF DURING THE CONICAL REVERSE REAMING. THE FINAL CONICAL REAMING WAS PERFORMED WITHOUT THE GUIDE. NO EFFECT WAS REPORTED FOR THE PATIENT. ACCORDING TO THE PROVIDED INFORMATION, THERE WAS NO SURGICAL DELAY. IT WAS REPORTED THAT THE INSTRUMENT WAS USED ACCORDING TO THE SURGICAL TECHNIQUE. EVENT HAPPENED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE MANUFACTURING CHARTS OF LOT #15AA115, NO ANOMALIES WERE DETECTED ON THE PRODUCTS MANUFACTURED WITH THE SAME 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 NARROW NOSE OF THE SMR - GUIDE FOR CONICAL REAMER (PRODUCT CODE 9013.52.116, LOT# 15AA115) SNAPPED OFF DURING THE CONICAL REVERSE REAMING. THE FINAL CONICAL REAMING WAS PERFORMED WITHOUT THE GUIDE. NO EFFECT WAS REPORTED FOR THE PATIENT. ACCORDING TO THE PROVIDED INFORMATION, THERE WAS NO SURGICAL DELAY. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910660 SMR - GUIDE FOR CONICAL REAMER GUIDE FOR CONICAL REAMER, KWS LIMACORPORATE S.P.A. 9013.52.116 15AA115

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other