BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAV FRAC PLT,CENTRAL THIRD,RT,SS

    MDR report key: 9631368 · Received January 27, 2020

    Report

    Report Number
    1220246-2020-01604
    Event Type
    Injury
    Date Received
    January 27, 2020
    Date of Event
    October 18, 2019
    Report Date
    March 9, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867027459
    PMA / PMN Number
    K143139
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED, THE PLATE BROKE INTO TWO PIECES NEAR THE MIDDLE OBLONG HOLE. EVALUATION SHOWS THE PLATE WAS BENT ABOUT 30 DEGREES BEFORE BREAKING. LIKELY CAUSES INCLUDE NOT FOLLOWING PROPER SURGICAL TECHNIQUE, POST-OP NONCOMPLIANCE PRIOR TO FULL BONE HEALING. PER SURGICAL TECHNIQUE, BENDING THE PLATE WITH EXCESSIVE ACUTE ANGLES MAY POTENTIALLY LEAD TO PLATE FATIGUE, FAILURE, AND/OR BREAKAGE IN-SITU.

    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 WAS REPORTED BY THE (B)(6) THAT A PATIENT HAD A PRIMARY PROCEDURE ON (B)(6) 2019 IN WHICH AN AR-2653CR CLAVICLE FRACTURE PLATE CENTRAL THIRD (RIGHT) WITH INTER SCREWS WAS IMPLANTED. A REVISION RIGHT CLAVICLE HARDWARE REMOVAL PROCEDURE TOOK PLACE ON (B)(6) 2019 AND WAS PERFORMED BY THE SAME SURGEON WHO PERFORMED THE PRIMARY. THE REVISION PROCEDURE OPERATIVE REPORT NOTES AN ARTHREX TEN HOLE CLAVICLE PLATE (RIGHT) BROKE IN THE FIFTH SCREW SLOT FROM THE LATERAL EDGE. SURGEON ALSO NOTED THAT AT THE SIXTH SCREW HOLE THERE WAS BENDING OF THE PLATE NOT OBVIOUSLY APPRECIATED ON THE X-RAY. THE FOLLOWING ARTHREX PRODUCT WAS IMPLANTED DURING THE PRIMARY (B)(6) 2019 PROCEDURE, AND EXPLANTED DURING THE (B)(6) 2019 REVISION PROCEDURE; AR-2653CR // LOT: 6791239 // QTY.: 1, AR-2665-14H // LOT: 1003473 // QTY.: 1, AR-8835-10 // LOT: 031640 // QTY.: 2, AR-8835-12 // LOT: 10212120 // QTY.: 1, AR-8835-14 // LOT: 10325008 // QTY.: 3, AR-8835-14 // LOT: 10325012 // QTY.: 1, AR-8835-14 // LOT: 10325213 // QTY.: 1, AR-8835-16 // LOT: 10344449 // QTY.: 1, AR-8840-10 // LOT: 10010746 // QTY.: 1. THERE WAS NOT AN ARTHREX SALES REPRESENTATIVE PRESENT DURING THE REVISION PROCEDURE. THE LEAD NURSE REPORTED TO THE REP THAT THE PATIENT CLAIMS THEY WERE LYING IN BED AND FELT A "POP." THE REP REPORTED THAT ALL EXPLANTED HARDWARE IS IN THEIR POSSESSION AND WILL BE RETURNING TO ARTHREX. ADDITIONAL INFORMATION OBTAINED 1/13/2020: THE OREGON MEDICAL BOARD REPORTER HAS PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE ON (B)(6) 2019 WAS TO REMOVE A TEN-HOLE ARTHREX PLATE AND INSTALL AN EIGHT-HOLE REPLACEMENT DEVICE IN THE PATIENT'S RIGHT CLAVICLE. IT IS UNKNOWN IF THE REPLACEMENT DEVICE THAT WAS IMPLANTED WAS MANUFACTURED BY ARTHREX. THE REPLACEMENT DEVICE INSTALLED ON (B)(6) 2019 HAS SINCE BEEN REMOVED ON (B)(6) 2019 BY A DIFFERENT SURGEON, AT A DIFFERENT FACILITY, DUE TO INFECTION. THE PRE AND POST OPERATIVE DIAGNOSIS WAS "INFECTED RIGHT CLAVICLE WITH HARDWARE FAILURE OF PLATE FIXATION". THE TYPE OF INFECTION ISN'T CLEAR BUT THE RECORDS REFERENCE STAPHYLOCOCUS THAT WAS RESISTANT TO PENICILLIN. NO PLATES OR OTHER DEVICES WERE INSTALLED DURING THE (B)(6) 2019 PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94142 CLAV FRAC PLT,CENTRAL THIRD,RT,SS PLATE, FIXATION, BONE HRS ARTHREX, INC. CLAV FRAC PLT,CENTRAL THIRD,RT,SS 6791239 00888867027459

    Patients

    Seq Age Sex Outcome Treatment
    1 Other