BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARUS® 3 NAIL TARGETING LOCKING BOLT

    MDR report key: 15265056 · Received August 22, 2022

    Report

    Report Number
    3025141-2022-00257
    Event Type
    Malfunction
    Date Received
    August 22, 2022
    Report Date
    December 16, 2022
    Manufacturer
    ACUMED, LLC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION WERE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED, AND NO ANOMALIES WERE NOTED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FOR EVALUATION ON 08 DECEMBER 2022, AND THE DEVICE EVALUATION WAS COMPLETED ON 14 DECEMBER 2022. ADDITIONAL CLARIFYING INFORMATION REGARDING THE EVENT HAS STILL NOT BEEN RECEIVED. THE PART NUMBER 80-1625 POLARUS 3 NAIL TARGETING LOCKING BOLT BATCH NUMBER 398349 WAS RETURNED. A FUNCTIONALITY TEST WAS CONDUCTED BY FOLLOWING THE ACUMED POLARUS 3 SOLUTION SURGICAL TECHNIQUE, PROXIMAL NAIL SURGICAL TECHNIQUE STEP 6: TARGETING GUIDE ASSEMBLY. THE RIGHT-SIDE TARGETING GUIDE WAS ASSEMBLED INITIALLY WITH ALL COMPONENTS SOURCED FROM THE KNOWN-FUNCTIONAL ENGINEERING LAB KIT, AND THEN RE-ASSEMBLED WITH THE RETURNED LOCKING BOLT SWAPPED IN. RESULTS WERE THAT NO DIFFERENCES WERE OBSERVED IN EITHER ASSEMBLY; BOTH ASSEMBLIES SUITABLY RETAINED A RIGHT-SIDE NAIL FLUSH TO THE RIGHT-SIDE TARGETING GUIDE ASSEMBLY SUCH THAT ALL HOLES ON THE NAIL COULD BE TARGETED ACCURATELY BY THE GUIDE. NO ISSUES WERE ENCOUNTERED WITH THE RETURNED PART. ADDITIONAL OBSERVATIONS: THE CUSTOMER EVENT NOTED THAT THE RETURNED LOCKING BOLT "CAUSED THE NAIL TO 'SLIP' MEANING THAT THEY COULD NOT LINE UP THE NAIL WITH THE JIG TO PLACE THE SCREWS." HOWEVER, IN-LAB TESTS WERE UNABLE TO REPLICATE THIS REPORTED ISSUE; THE ASSEMBLY WITH LAB COMPONENTS SUCCESSFULLY SECURED THE NAIL WITHIN THE POLARUS 3 TARGETING GUIDE SUCH THAT THE NAIL HOLES COULD BE TARGETED. IT IS POSSIBLE THAT ANY OTHER COMPONENT OF THE CUSTOMER'S POLARUS 3 ASSEMBLY COULD HAVE CONTRIBUTED TO IN-FIELD ISSUES, AS WELL AS THE NAIL ITSELF. AS NONE OF THESE PARTS WERE PROVIDED/RETURNED FOR EVALUATION, THIS COULD NOT BE DEFINITIVELY DETERMINED. THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THERE WAS AN ISSUE WITH THE PART NUMBER 80-1625 POLARUS 3 NAIL TARGETING LOCKING BOLT (BATCH # 398349). IT WAS REPORTED THE TARGETING LOCKING BOLT "CAUSED THE NAIL TO 'SLIP,' MEANING THAT THEY COULD NOT LINE UP THE NAIL WITH THE JIG TO PLACE THE SCREWS." DEVICE INFORMATION FOR THE NAIL INVOLVED IN THIS EVENT IS UNKNOWN. ATTEMPTS TO OBTAIN FURTHER INFORMATION REGARDING THIS EVENT AND THE PATIENT WERE MADE TO NO AVAIL. THIS REPORT IS RELATED TO REPORT NUMBER 3025141-2022-00258 FOR THE NAIL INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2487494 POLARUS® 3 NAIL TARGETING LOCKING BOLT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ACUMED, LLC 80-1625 398349

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown