BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVER ARM MOTOR UNIT

    MDR report key: 14582947 · Received June 2, 2022

    Report

    Report Number
    2027754-2022-00027
    Event Type
    Malfunction
    Date Received
    June 2, 2022
    Report Date
    June 16, 2022
    Manufacturer
    OSTEOMED, LLC
    Product Code
    KMW
    UDI-DI
    084569415646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND. THE REVIEW REVEALED THE DEVICE HAD BEEN TESTED AND MET SPECIFICATIONS. ADDITIONALLY, ALL INSPECTIONS HAD PASSED. THE DEVICE HAD BEEN RETURNED UNDER A SERVICE WORK ORDER (SRO) DURING WHICH IT WAS IDENTIFIED THAT THE DEVICE WAS CONTINUOUSLY RUNNING DUE TO MALFUNCTION OF THE CABLE ASSEMBLY. THE DEVICE WAS REPAIRED UNDER THE SRO AND WAS SUBSEQUENTLY TESTED AND MET SPECIFICATIONS. THE DEVICE IS A REUSABLE INSTRUMENT AND WAS MANUFACTURED IN 2016; THEREFORE, IT IS UNKNOWN HOW MANY TIMES THE DEVICE WAS USED PRIOR TO THIS REPORTED COMPLAINT EVENT NOR UNDER WHAT CIRCUMSTANCES IT WAS USED. BASED ON THE INFORMATION AVAILABLE, THE ROOT CAUSE COULD NOT BE DETERMINED. ATTEMPTS ARE BEING MADE TO OBTAIN FURTHER INFORMATION REGARDING THE FINDINGS OF THE SRO, AND A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    H6: TYPE OF INVESTIGATION- CORRECTED TO 10 (TESTING OF ACTUAL/SUSPECT DEVICE) AND 3331 (ANALYSIS OF PRODUCTION RECORDS). 4117 (DEVICE NOT ACCESSIBLE FOR TESTING) WAS SELECTED IN ERROR.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED ON 15 JUNE 2022 AFTER FOLLOW UP ATTEMPTS TO OBTAIN MORE INFORMATION FOLLOWING THE FINDINGS OF THE SERVICE REPAIR. IT WAS REPORTED ON 15 JUNE 2022 THAT THE ISSUE WITH THE DEVICE WAS THE "LEVER ARM MOTOR UNIT WAS NOT WORKING". NO FURTHER INFORMATION REGARDING HOW IT WAS NOT WORKING AND THE CIRCUMSTANCES SURROUNDING THIS ISSUE WAS PROVIDED OR AVAILABLE.

    Description of Event or Problem · 0

    A SERVICE REQUEST FOR THE DEVICE WAS RECEIVED ON (B)(6) 2022 WITH NO PRODUCT COMPLAINT MADE. ON (B)(6) 2022, THE SERVICE REQUEST WORK ORDER WAS COMPLETED. DURING THE SERVICE REQUEST WORK ORDER, IT WAS NOTED THE DEVICE WAS RUNNING CONTINUOUSLY DUE TO A MALFUNCTIONING CABLE ASSEMBLY. AS A RESULT OF THESE FINDINGS OF THE SERVICE REQUEST WORK ORDER, THIS REPORT IS BEING SUBMITTED. ADDITIONALLY, AS A RESULT OF THE SERVICE REQUEST WORK ORDER, THE CUSTOMER IS BEING CONTACTED TO OBTAIN ADDITIONAL INFORMATION REGARDING THESE FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1833548 LEVER ARM MOTOR UNIT HANDPIECE, ROTARY BONE CUTTING KMW OSTEOMED, LLC 450-0034 1100448 084569415646

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown