BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IM REAMER, AO FITTING BIXCUT 8,0X480 MM

    MDR report key: 10278884 · Received July 15, 2020

    Report

    Report Number
    0009610622-2020-00321
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    June 17, 2020
    Report Date
    October 6, 2020
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    UDI-DI
    04546540145338
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD BE CONFIRMED, SINCE THE DEVICE WAS RETURNED FOR EVALUATION AND MATCHES THE ALLEGED FAILURE, ALTHOUGH THE REAMER HAD BEEN REFURBISHED EXTERNALLY BY A THIRD PARTY. THE RETURNED IM REAMER (LOT# K0C08F1), ALTHOUGH WAS FOUND TO BE BROKEN, HAD BEEN REFURBISHED AS INDICATED BY A THIRD PARTY ENGRAVING ON THE ADAPTER. THUS, FURTHER INSPECTION IS DEEMED DISPENSABLE. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. BASED ON THE INVESTIGATION IT WAS FOUND THAT ALTHOUGH THERE WAS FAILURE CONFIRMATION BUT THERE WAS ALREADY A REFURBISHMENT DONE TO THE REAMER AS INDICATED BY THE ENGRAVING ON THE ADAPTER. THIS MARKING IS NOT MADE BY STRYKER AT ANY POINT OF TIME. INSTRUMENTS WHICH ARE REFURBISHED BY THIRD PARTIES/EXTERNAL SOURCES AND THEN RETURNED TO THE CUSTOMERS ARE NOT REGARDED TO HAVE BEEN PUT ON THE MARKET BY STRYKER. AFTER ANY SORT OF REWORK DONE EXTERNALLY, THEY BECOME PRODUCTS OF A THIRD PARTY. THERE ARE NO WARRANTY CLAIMS AGAINST STRYKER FOR THIRD-PARTY PRODUCTS. IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED TO SALES REP THAT: "BREAKAGE OF A REAMER DURING PROCEDURE" PROCEDURE ENDED BY CHANGING REAMER". EMAIL FROM CUSTOMER FROM (B)(6) 2020 : UPDATE ¿INDEED I CAN CONFIRM WE HAVE A REAMER BIXCUT STRYKER DIAM 8 REF K0008F1 THAT BROKE DURING THE SURGERY ON (B)(6) 2020.".

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF INVESTIGATION, ADDITIONAL INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO SALES REP THAT: "BREAKAGE OF A REAMER DURING PROCEDURE" PROCEDURE ENDED BY CHANGING REAMER." EMAIL FROM CUSTOMER FROM 26-06-2020 : UPDATE ¿INDEED I CAN CONFIRM WE HAVE A REAMER BIXCUT STRYKER DIAM 8 REF K0008F1 THAT BROKE DURING THE SURGERY ON (B)(6) 2020."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744722 IM REAMER, AO FITTING BIXCUT 8,0X480 MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL 0225-6080 K0C08F1 04546540145338

    Patients

    Seq Age Sex Outcome Treatment
    1