BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5967506 · Received September 21, 2016

    Report

    Report Number
    2520274-2016-14621
    Event Type
    Injury
    Date Received
    September 21, 2016
    Report Date
    September 1, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K010766
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR UNKNOWN SCREW/UNKNOWN LOT NUMBER. PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED FOR THE UNKNOWN SCREW, AN INVESTIGATION COULD NOT BE PERFORMED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4) THE COMPLAINT INDICATED THAT THE SCREW WAS BROKEN POST-OP WITH AN ASSOCIATED NON-UNION REQUIRING ADDITIONAL SURGICAL INTERVENTION. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEFT FEMORAL NECK REVISION WAS PERFORMED ON (B)(6) 2016 FOR A NON-UNION ((B)(4)). DURING THE ORIGINAL SURGERY, A PLATE AND EIGHT SCREWS WERE IMPLANTED. DURING THE REMOVAL, ALL IMPLANTS HAD BEEN INTACT BUT ONE SCREW WAS BROKEN. THE BROKEN SCREW WAS REVEALED ON X-RAYS DURING THE PROCEDURE. ALL PARTS OF THE BROKEN SCREW WERE REMOVED AND NO FRAGMENTS REMAINED IN THE PATIENT. THE PATIENT WAS REVISED WITH A VALGUS OSTEOTOMY AND BONE GRAFTING; A 6-HOLE 140 DEGREE LOCKING COMPRESSION PLATE (LCP), DYNAMIC HELICAL HIP SYSTEM (DHHS) PLATE AND AN UNKNOWN QUANTITY OF SCREWS. DURING THE IMPLANTATION OF THE DHHS PLATE AND SCREWS, WHILE ATTEMPTING TO PLACE ONE CORTEX SCREW, THE LARGE HEXAGONAL SCREWDRIVER HEAD BROKE OFF ((B)(4)). THE PIECE WAS RETRIEVED AND A BACKUP SCREWDRIVER WAS USED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A ONE MINUTE SURGICAL DELAY AND NO OTHER MEDICAL SURGICAL INTERVENTION. THE PATIENT STATUS/OUTCOME IS FINE. THIS COMPLAINT INVOLVES ONE DEVICE. CONCOMITANT DEVICES REPORTED: LOCKING COMPRESSION PLATE (LCP) DYNAMIC HELICAL HIP SYSTEM (DHHS) PLATE - (PART#240.161, LOT# 1240809, AND A QUANTITY# OF ONE); UNKNOWN SCREWS - PART#-UNKNOWN, LOT#-UNKNOWN, QUANTITY# - SEVEN) AND CORTEX SCREW - (PART#-UNKNOWN, LOT#-UNKNOWN, AND A QUANTITY# OF ONE). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618264 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 240.161,4.5MM LCP® T-PLATE 6 HOLES 115MM| CORTEX SCREW - PART#-UNK, LOT#-UNK, QTY 1| UNKNOWN SCREWS - PART#-UNK, LOT#-UNK QTY 7