BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSURE HA 7MM X 25MM

    MDR report key: 8134094 · Received December 5, 2018

    Report

    Report Number
    1219602-2018-01665
    Event Type
    Malfunction
    Date Received
    December 5, 2018
    Date of Event
    November 19, 2018
    Report Date
    January 12, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HWC
    UDI-DI
    03596010611680
    PMA / PMN Number
    K080358
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION. FOREIGN POST CODE - (B)(4). ONE 7220177 2 7X25MM BIOSURE HA SCREW REPORTED ON. DUE TO UNAVAILABILITY, THE ALLEGATION COULD NOT BE FULLY CONFIRMED. DEFINITIVE CONCLUSIONS, INVESTIGATION AND EVALUATION WERE NOT POSSIBLE WITHOUT PHYSICAL EVALUATION. IF OBJECTIVE EVIDENCE BECOMES AVAILABLE TO ASSIST WITH EVALUATION, THE COMPLAINT WILL BE REVISITED. FACTORS THAT MAY AFFECT DEVICE PERFORMANCE INCLUDE: DEVICE STORAGE, DEVICE ABILITY, SURGICAL ABILITY, PROCEDURE LOCATION AND TISSUE CONDITION. INFLUENCES THAT COULD COMPROMISE PRODUCT PERFORMANCE OR INTEGRITY INCLUDE: ETTING ENTANGLED UP WITH OTHER INSTRUMENTS OR DEVICES. STRIPPING OR OVER-TORQUE. USE OF OTHER THAN RECOMMENDED PREP INSTRUMENT SIZE OR TYPES. DAMAGED PREP INSTRUMENTS. UNEXPECTED BONE DENSITY/CONDITION. REVIEW OF INSTRUCTION FOR USE DOCUMENTATION CONFIRMS INSTRUCTIONS, PRECAUTIONARY STATEMENTS AND RECOMMENDATIONS FOR PROPER USE OF PRODUCT. PREPARATION PER THE INSTRUCTION FOR USE RECOMMENDATION IS CRITICAL FOR EASE OF INSERTION AND SUCCESSFUL ANCHORING: ¿THE STARTER MUST BE UTILIZED WITH THE BIORCI SCREWS TO MINIMIZE SCREW BREAKAGE DURING INSERTION. PRIOR TO USE INSPECT THE TIP OF THE DRIVER. IF TIP FLARING IS APPARENT DO NOT USE THE DRIVER. EXCESSIVE FORCE SHOULD NOT BE PLACED ON THE DELIVERY INSTRUMENT. IN CASES WHERE HARD BONE IS ENCOUNTERED, IT IS RECOMMENDED THAT A TAP 1 MM LARGER THAN THE SCREW SIZE BE USED¿, FINAL PRODUCT MET SPECIFICATIONS UPON RELEASE TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED AN UNKNOWN DELAY BECAUSE THE SCREW BROKE WHEN IT WAS INSERTING INTO THE PATIENT'S BONE. UNKNOWN IF BACKUP WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED. UNKNOWN IF THE PIECES WERE RETRIEVED, BUT NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW BROKE WHEN IT WAS INSERTING INTO THE PATIENT'S BONE. THERE WAS A BACKUP WAS AVAILABLE. NO NEW BONE HOLE WAS NECESSARY TO COMPLETE THE PROCEDURE. THE PIECES WERE RETRIEVED AND NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972668 BIOSURE HA 7MM X 25MM SCREW, FIXATION, BONE HWC SMITH & NEPHEW, INC. 50722229 03596010611680

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR