BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACU-LOC® 2 VDR PROXIMAL T-GUIDE NARROW R

    MDR report key: 18340841 · Received December 15, 2023

    Report

    Report Number
    3025141-2023-00722
    Event Type
    Malfunction
    Date Received
    December 15, 2023
    Date of Event
    November 20, 2023
    Report Date
    December 14, 2023
    Manufacturer
    ACUMED, LLC
    Product Code
    HWC
    PMA / PMN Number
    K102998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED, AND NO ANOMALIES WERE FOUND. THE ACU-LOC® 2 VDR PROXIMAL T-GUIDE NARROW R (PART NUMBER 80-0702, BATCH NUMBER 308626) WAS RETURNED FOR EVALUATION. THE RETURNED T-GUIDE WAS EXAMINED WITH MAGNIFIED PHOTOGRAPHY. A LARGE V-SHAPED NOTCH WAS PRESENT IN THE MOST DISTAL WALL OF THE TGT GUIDE, SPECIFICALLY OBSCURING MULTIPLE LASER MARKS OF THE DEVICE. THE DAMAGE CUT INTO AND THROUGH THE MIDDLE HOLE OF THE DISTAL ROW. THIS NOTCH MAY BE DUE TO FRAGMENTATION OF THIS REGION, WITH A CHUNK OF THE TGT GUIDE POTENTIALLY HAVING BEEN SEPARATED FROM THE MAIN BODY; THIS COULD NOT BE CONFIRMED, AS THERE WERE NO SEPARATE FRAGMENTS RETURNED WITH THE TGT GUIDE. THE BREAKAGE/NOTCH EXTENDS FURTHER DOWNWARDS TO THE UNDERSURFACE OF THE GUIDE VIA A HAIRLINE CRACK/FRACTURE. DAMAGE WAS PRESENT AT THE EDGES OF HOLES; THIS INCLUDES LIGHT WEARING OR REMOVAL OF MATERIAL ON EDGES, AS WELL AS A LARGE QUANTITY OF NICKS/CUTS INTO THE THIN-WALL EDGES BETWEEN HOLES. THEREFORE, BASED ON THE INFORMATION RECEIVED THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING SURGERY THAT THE ACU-LOC® 2 VDR PROXIMAL T-GUIDE NARROW R (PART NUMBER 80-0702, BATCH NUMBER 308626) BROKE. NO BROKEN PIECES OF THE GUIDE WERE LEFT BEHIND IN THE PATIENT. IT WAS ALSO REPORTED AN 80-0249 (2.0MM LOCKING DRILL GUIDE 4MM-32MM) WAS USED TO COMPLETE THE SURGERY WITH NO DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1098609 ACU-LOC® 2 VDR PROXIMAL T-GUIDE NARROW R SCREW, FIXATION, BONE HWC ACUMED, LLC 80-0702 308626

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown