BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK CONNECT RECIPROCATING SAW

    MDR report key: 19918756 · Received August 6, 2024

    Report

    Report Number
    2027754-2024-00041
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Report Date
    August 6, 2024
    Manufacturer
    OSTEOMED, LLC
    Product Code
    KMW
    UDI-DI
    00845694037167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS OPENED AS A RESULT OF THE DIAGNOSIS FINDINGS DURING SRO REVIEW. THE DEVICE HAD BEEN RETURNED UNDER SRO NUMBER (B)(4) FOR SERVICE AND REPAIR. THE DIAGNOSIS BY THE SERVICE AND REPAIR TEAM WAS DETERMINED TO BE " WHEN RUNNING AT 75% SPEED AS RECOMMENDED, THE SAW BLADE WILL BE LOOSENED AND FINALLY EJECTED FROM THE HANDPIECE". REPAIR ON THE DEVICE WILL BE COMPLETED PER THE SRO WORK ORDER. ADDITIONALLY, THE DEVICE WILL BE TESTED TO ENSURE ALL SPECIFICATIONS ARE MET, PRIOR TO RETURN TO THE CUSTOMER. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE REPORTED DEVICE REVEALED NO ANOMALIES. A REVIEW OF THE COMPLAINT DATABASE FOR PART NUMBER 450-0241 REVEALED ONLY ONE (1) COMPLAINT FOR BLADE NOT RETAINED DURING USE, WHICH IS THE EVENT IN THIS REPORT. THE DEVICE IS A REUSABLE INSTRUMENT; 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 RECEIVED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    DURING REVIEW OF THE SERVICE AND REPAIR ORDER (SRO) LOG, IT WAS NOTED THE DEVICE EVACUATION/DIAGNOSIS STATED "WHEN RUNNING AT 75% SPEED AS RECOMMENDED, THE SAW BLADE WILL BE LOOSENED AND FINALLY EJECTED FROM THE HANDPIECE". FOLLOW UP WAS CONDUCTED BY THE CUSTOMER WHO REPORTED THIS ISSUE OCCURRED DURING A SURGERY. ADDITIONAL INFORMATION PROVIDED INDICATED THE SAW BLADE KEPT LOOSENING FROM THE HANDPIECE BUT WOULD STILL "GET THE JOB DONE" ALTHOUGH THEY HAD TO KEEP PUSHING THE BLADE IN THE HANDPIECE. THE SURGERY WAS NOT PROLONGED, AND THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1673784 QUICK CONNECT RECIPROCATING SAW HANDPIECE, ROTARY BONE CUTTING KMW OSTEOMED, LLC 450-0241 1179693 00845694037167

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown