BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCR BIORCI 8X30MM STRL BX 1

    MDR report key: 9926978 · Received April 5, 2020

    Report

    Report Number
    1219602-2020-00598
    Event Type
    Malfunction
    Date Received
    April 5, 2020
    Date of Event
    March 10, 2020
    Report Date
    May 4, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HWC
    UDI-DI
    03596010426239
    PMA / PMN Number
    K992396
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3,H6: ONE 7207561 STERILE BIORCI 8X30MM SCREW WAS USED FOR TREATMENT, WAS NOT RETURNED FOR EVALUATION. DUE TO PRODUCT UNAVAILABILITY, THE EVALUATION WAS LIMITED. IF FURTHER INFORMATION BECOMES AVAILABLE THE COMPLAINT MAY 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: 1. USE OF OTHER THAN RECOMMENDED PREP INSTRUMENT SIZE OR TYPES. 2. ENTANGLEMENT WITH GUIDE WIRE OR OTHER INSTRUMENT. 3. STRIPPING OR OVER-TORQUE. 4. DAMAGED PREP INSTRUMENTS. 5. NOT ACCOUNTING FOR TAPER OR LARGER HEAD TO BODY DESIGN. 6. UNEXPECTED BONE DENSITY/CONDITION. REVIEW OF INSTRUCTION FOR USE (IFU) DOCUMENTATION CONFIRMS INSTRUCTIONS, PRECAUTIONARY STATEMENTS AND RECOMMENDATIONS FOR PROPER USE OF PRODUCT. PREP PER THE IFU RECOMMENDATION IS CRITICAL FOR EASE OF INSERTION AND SUCCESSFUL ANCHORING. PER IFU 1060635: ¿IT IS THE SURGEON¿S RESPONSIBILITY TO BE FAMILIAR WITH THE APPROPRIATE SURGICAL TECHNIQUES PRIOR TO USE OF THIS DEVICE. READ THESE INSTRUCTIONS COMPLETELY PRIOR TO USE. 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. IF HARD BONE IS ENCOUNTERED, THE BIORCI TAP SHOULD BE USED.¿ COMPLAINT HISTORY REVIEW INDICATED A SIMILAR ALLEGATION FOR THE LOT NUMBER REPORTED. BATCH REVIEW DID NOT INDICATE A FAILURE THAT SUPPORTED THE ALLEGATION. PRODUCT MET SPECIFICATIONS UPON RELEASE TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TIBIAL FIXATION THE BIORCI SCREW BROKE WHILE IT WAS SCREWING INTO THE BONE. THE BROKEN PIECE WAS RETRIEVED USING A GRASPER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390151 SCR BIORCI 8X30MM STRL BX 1 SCREW, FIXATION, BONE HWC SMITH & NEPHEW, INC. 7207561 50762637 03596010426239

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR