BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LO-PRO LOCK SCRW,TI,3.0MMX 18MM

    MDR report key: 8930502 · Received August 26, 2019

    Report

    Report Number
    1220246-2019-01270
    Event Type
    Injury
    Date Received
    August 26, 2019
    Date of Event
    May 15, 2019
    Report Date
    August 26, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867050068
    PMA / PMN Number
    K143614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT A PATIENT HAD UNDERGONE A PREVIOUS KNEE SURGERY USING ANOTHER MANUFACTURER¿S PRODUCT. APPROXIMATELY ONE WEEK LATER THE PATIENT THEN UNDERWENT A REVISION PROCEDURE USING AN ARTHREX PATELLA SUTUREPLATE STAR SMALL, ON (B)(6) 2019 (CASE (B)(4)). AT TIME OF SURGERY THE INTER-OPERATIVE X-RAY LOOKED GOOD. HOWEVER, ONE DAY AFTER THE SURGERY IT WAS NOTICED ON A SECOND X-RAY THAT THE FRACTURE GAP WAS OPEN AND TOO FAR APART. THE PATIENT WAS SCHEDULED FOR A REVISION SURGERY. ON (B)(6) 2019 THE PATIENT UNDERWENT A REVISION PROCEDURE TO REMOVE THE FOLLOWING IMPLANTS: AR-13059S (LOT 6045180600 - QTY1) PATELLA SUTUREPLATE STAR SMALL (NOT SOLD IN US); AR-8935L-22 (LOT W46320 - QTY 2) LOCKING SCREW; AR-8935L-20 (LOT 10224133 -QTY 3) LOCKING SCREW; AR-8935L-20 (LOT 1009169 - QTY 1) LOCKING SCREW; AR-8935L-18 (LOT 1011926 -QTY 1) LOCKING SCREW; AR-8935L-18 (LOT W584981 -QTY1) LOCKING SCREW. TO COMPLETE THE REVISION PROCEDURE THE SURGEON IMPLANTED AN ARTHREX PATELLA SUTUREPLATE II (SIZE L) WITH CORRESPONDING ARTHREX SCREWS. THE SURGEON TOOK AN X-RAY AND NOTICED THAT THE SIZE L PLATE WAS TOO BIG. SURGEON REMOVED THE PATELLA SUTUREPLATE II (SIZE L) AND SCREWS. SURGEON THEN CHANGED THE PATELLA SUTUREPLATE II TO SIZE M USING DIFFERENT SCREWS. SINCE SO MANY SCREWS WERE OPENED DURING THE PROCEDURE IT WAS UNKNOWN WHICH SCREWS WERE USED AND REMOVED WITH THE SIZE L PATELLA SUTUREPLATE II AND WHICH WERE USED WITH THE SIZE M PATELLA SUTUREPLATE II AND LEFT IN THE PATIENT. THE FOLLOWING IS THE SIZE M PATELLA SUTUREPLATE II PART NUMBER AND LIST OF ALL SCREWS THAT WERE OPENED AND USED DURING THE PROCEDURE. AR-13070M-P-S (LOT 1448182600 -QTY 1) PATELLA SUTUREPLATE II STAR POLE FRACTURE M (NOT SOLD IN US); AR-8933L-22 (LOT 31807 - QTY 4) LOW PROFILE LOCKING SCREW; AR-8933L-20 (LOT 1047007 - QTY 3) LOW PROFILE LOCKING SCREW; AR-8933L-20 (LOT W5456511 - QTY 1) LOW PROFILE LOCKING SCREW; AR-8933L-18 (LOT 1047304 - QTY 4) LOW PROFILE LOCKING SCREW. IT HAS SINCE BEEN REPORTED THAT PATIENT UNDERWENT ANOTHER REVISION ON (B)(6) 2019 WHICH TOOK PLACE AT A DIFFERENT FACILITY USING ANOTHER MANUFACTURER¿S SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723352 LO-PRO LOCK SCRW,TI,3.0MMX 18MM SCREW, FIXATION, BONE HWC ARTHREX, INC. LO-PRO LOCK SCRW,TI,3.0MMX 18MM 1047304 00888867050068

    Patients

    Seq Age Sex Outcome Treatment
    1 Other