BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA FAST-FIX ASSEMBLY - CURVED, EI

    MDR report key: 7869579 · Received September 12, 2018

    Report

    Report Number
    1219602-2018-01245
    Event Type
    Malfunction
    Date Received
    September 12, 2018
    Date of Event
    July 11, 2018
    Report Date
    November 30, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    UDI-DI
    00885554028591
    PMA / PMN Number
    K121861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Additional Manufacturer Narrative · 1

    ONE (B)(4) ULTRA-FAST-FIX ASSEMBLY-CURVED EXTENDED IMPLICATIONS DEVICE REPORTED ON. THE COMPLAINT INDICATED DIFFICULTY WITH USE AND AN UNKNOWN NOISE HEARD. THE SECOND ANCHOR WAS SUCCESSFUL. LATER OBSERVATION FOUND THE DEVICE TO BE BROKEN AND A PIECE MISSING. THE SEGMENT WAS CONFIRMED INSIDE THE PATIENT VIA X-RAY. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. DUE TO PRODUCT UNAVAILABILITY, THE COMPLAINT COULD NOT BE ULTIMATELY CONFIRMED. FULLY DEFINITIVE CONCLUSIONS, ACCURATE INVESTIGATION AND EVALUATION ARE NOT POSSIBLE WITHOUT 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. THIS STYLE OF DELIVERY SYSTEM REQUIRES MANUAL TRIGGER ADVANCEMENT TO POSITION AND PLACE THE ANCHORS. THEY ARE EACH THEN MANUALLY STRIPPED OFF THE NEEDLE TIP. INFLUENCES THAT COULD COMPROMISE PRODUCT PERFORMANCE OR INTEGRITY THAT ARE UNRELATED TO MANUFACTURE INCLUDE: 1) INADVERTENT FORCE INVOLVING TWISTING, BENDING MANIPULATION OF THE DELIVERY NEEDLE. 2) DIFFICULTY WITH REACHING THE DESIRED TISSUE LOCATION. 3) INADEQUATE TISSUE CONDITIONS. 4) DAMAGE INDICATING THAT THE NEEDLE MET WITH A SOLID SURFACE SUCH AS BONE OR ENTANGLED WITH AN INSTRUMENT. REVIEW OF INSTRUCTION FOR USE (IFU) DOCUMENTATION CONFIRMS INSTRUCTIONS, PRECAUTIONARY STATEMENTS AND RECOMMENDATIONS FOR PROPER USE OF PRODUCT. PER IFU: ¿DO NOT BEND THE DELIVERY NEEDLE.¿ TWIST OR BEND CAN INTERFERE WITH ADVANCEMENT AND REMOVAL OF T¿S. FINAL PRODUCT MET PREDETERMINED SPECIFICATIONS UPON RELEASE TO DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    ONE 72203718 ULTRA-FAST-FIX ASSEMBLY-CURVED EXTENDED IMPLICATIONS DEVICE RETURNED. TWIST OR BEND CAN INTERFERE WITH SUCCESS OF DEVICE AND ADVANCEMENT OR RELEASE OF T¿S. THE NEEDLE¿S CONDITION IS CONSISTENT WITH EXCESSIVE MANIPULATION OR GETTING ENTANGLED/ SEVERED BY AN INSTRUMENT. IT IS ALSO CONSISTENT WITH DIFFICULT USE IN REACHING DESIRED TISSUE LOCATION. SINCE IT WAS STATED THAT THE SECOND ANCHOR WAS SECURED AND LATER OBSERVATION FOUND THE DEVICE TO BE BROKEN WITH A PIECE MISSING, THE DAMAGE WOULD HAVE HAD TO OCCUR DURING RETRACTION POST T2 ANCHORING. FACTORS THAT MAY AFFECT DEVICE PERFORMANCE INCLUDE: DEVICE ABILITY, SURGICAL ABILITY, IMPLANT LOCATION AND TISSUE CONDITION. THIS STYLE OF DELIVERY SYSTEM REQUIRES MANUAL LEVER ADVANCEMENT TO POSITION AND PLACE THE ANCHORS. THEY ARE THEN EACH MANUALLY STRIPPED OFF THE NEEDLE TIP. INFLUENCES THAT COULD COMPROMISE PRODUCT PERFORMANCE OR INTEGRITY THAT ARE UNRELATED TO MANUFACTURE INCLUDE: INADVERTENT FORCE INVOLVING TWISTING, BENDING MANIPULATION OF THE DELIVERY NEEDLE. DIFFICULTY WITH REACHING THE DESIRED TISSUE LOCATION. INADEQUATE TISSUE CONDITIONS. DAMAGE FROM MEETING WITH A SOLID SURFACE SUCH AS BONE OR ENTANGLEMENT WITH ANOTHER INSTRUMENT. FINAL PRODUCT MET PREDETERMINED SPECIFICATIONS UPON RELEASE TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN RELOADING THE FAST-FIX WAS VERY DIFFICULT AT FIRST AND THERE WAS A LOUD CRACKLING NOISE. THE SECOND IMPLANT COULD BE SET AND KNOTTED. DURING THE COMPLETENESS CHECK, IT WAS FOUND THAT THE GUIDE RAIL WAS MISSING. IN THE X-RAY CONTROL, THIS GUIDE RAIL IS LOCATED IN THE FRONT KNEE IN THE HOFFAS FAT TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708503 ULTRA FAST-FIX ASSEMBLY - CURVED, EI SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 50715525 00885554028591

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR