BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER, BIOSURE SYNC

    MDR report key: 7952213 · Received October 10, 2018

    Report

    Report Number
    1219602-2018-01390
    Event Type
    Malfunction
    Date Received
    October 10, 2018
    Date of Event
    September 17, 2018
    Report Date
    November 21, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NBH
    UDI-DI
    03596010649010
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A 72202752 BIOSURE SYNC INSERTER INSTRUMENT WAS REPORTED ON. BASED UPON THE INFORMATION PROVIDED, THE FAILURE WAS WITH THE RADEL INSERTER GUIDE SHEATH THAT CRACKED. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. DUE TO PRODUCT UNAVAILABILITY, THE COMPLAINT COULD NOT BE ULTIMATELY CONFIRMED. DEFINITIVE CONCLUSIONS, ACCURATE INVESTIGATION AND EVALUATION WERE NOT FULLY POSSIBLE WITHOUT EVALUATION OF PHYSICAL PRODUCT. IF OBJECTIVE EVIDENCE, RELEVANT INFORMATION, PACKAGING OR PRODUCT BECOMES AVAILABLE TO ASSIST WITH EVALUATION, THE COMPLAINT WILL CERTAINLY BE REVISITED. FACTORS THAT MAY AFFECT DEVICE PERFORMANCE INCLUDE: DEVICE ABILITY, SURGICAL ABILITY, IMPLANT LOCATION AND TISSUE CONDITION. REVIEW OF INSTRUCTION FOR USE (IFU) (B)(4) DOCUMENTATION CONFIRMS INSTRUCTIONS, PRECAUTIONARY STATEMENTS AND RECOMMENDATIONS FOR PROPER USE OF PRODUCT. INFLUENCES THAT COULD COMPROMISE PRODUCT PERFORMANCE OR INTEGRITY THAT ARE UNRELATED TO MANUFACTURE INCLUDE: AS A REUSABLE DEVICE; PRIOR DAMAGE OR LOSS OF INTEGRITY UNREALIZED. INCOMPATIBLE CLEANING AGENTS CAUSING DEGRADATION TO COMPONENTS. CONFLICTING FORCE OR TORQUE APPLIED.

    Additional Manufacturer Narrative · 1

    ONE 72202752 BIOSURE SYNC INSERTER INSTRUMENT RETURNED. THE COMPLAINT INDICATED THAT THE FAILURE WAS WITH THE RADEL INSERTER GUIDE SHEATH THAT CRACKED. IT WAS RECEIVED WITH THAT COMPONENT ATTACHED. THERE WAS A PIECE OF THE SLEEVE MISSING WHERE IT HAD CRACKED. IT IS AT THE SPRING-LOADED LOCKING PIN SHOULD SEAT IN A NOTCH. AS WITH ANY SURGICAL INSTRUMENT, CAREFUL ATTENTION SHOULD BE EXERCISED TO ENSURE THAT EXCESSIVE FORCE IS NOT PLACED ON THE INSTRUMENT. EXCESSIVE FORCE CAN RESULT IN INSTRUMENT FAILURE. USE OF APPROVED CLEANING AGENTS MAY AFFECT PLASTIC AND DELRIN COMPONENTS. LOW-SUDSING, NEUTRAL 6.0¿8.0 PH, ENZYMATIC DETERGENTS ARE RECOMMENDED. DO NOT USE DETERGENTS ABOVE 11.0 PH. USE DEIONIZED WATER FOR WASHING AND RINSING. INSPECT THE DEVICE AND ANY FLEXIBLE PORTION FOR WEAR OR CRACKING. DISCARD THE DEVICE IF ANY WEAR IS OBSERVED OR IF THE TIP BECOMES DULL. AS WITH ANY SURGICAL INSTRUMENT, CAREFUL ATTENTION SHOULD BE EXERCISED TO ENSURE THAT EXCESSIVE FORCE IS NOT PLACED ON THE INSTRUMENT. EXCESSIVE FORCE CAN RESULT IN INSTRUMENT FAILURE. NO ROOT CAUSE RELATED TO THE MANUFACTURING OF THIS DEVICE WAS CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLACK PLASTIC SLEEVE BROKE OFF DURING IMPLANT INSERTION. CORRECT SURGICAL TECHNIQUE USED. PROPER SIZED DILATOR WAS USED PRIOR TO SYNC IMPLANT INSERTION. PLASTIC CHIP WAS RETRIEVED AND DISCARDED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793155 INSERTER, BIOSURE SYNC ACCESSORIES,ARTHROSCOPIC NBH SMITH & NEPHEW, INC. 72202752 50644810 03596010649010

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR