BEUDAMED
    FDA Adverse Event Other Summary report: N

    LOOK

    MDR report key: 2020232 · Received March 9, 2011

    Report

    Report Number
    2522801-2011-00003
    Event Type
    Other
    Date Received
    March 9, 2011
    Date of Event
    February 17, 2011
    Report Date
    March 9, 2011
    Manufacturer
    SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)
    Product Code
    GAL
    PMA / PMN Number
    K896554
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL FAILED DEVICES WERE NOT RETURNED FOR EVALUATION. HOWEVER, STERILE PRODUCT FROM THE SAME FINISHED GOOD LOT WAS RETURNED FOR EVALUATION. METHOD: THE ACTUAL FAILED DEVICES WERE NOT RETURNED FOR EVALUATION. HOWEVER, STERILE PRODUCT FROM THE SAME FINISHED GOOD LOT WAS RETURNED AND EVALUATED ON (B)(4) 2011, BY AN ANGIOTECH ENGINEER. RESULTS/CONCLUSION: THE ENGINEER VISUALLY INSPECTED THE NEEDLES AND REPORTED NO NON-CONFORMANCE ISSUES. EXPERIMENTAL FAILURE MODES WERE DUPLICATED IN THE TEST LABORATORY BY GRIPPING THE SWAGED AREA OF THE NEEDLE WITH NEEDLE FORCEPS AND APPLYING A LOAD AT THE TIP OF THE NEEDLE. THE NEEDLE BENDS BUT ULTIMATELY FAILS AT THE CLAMPED AREA. ADDITIONAL TESTS WERE PERFORMED BY GRIPPING THE NEEDLE ABOVE THE SWAGED AREA. THE NEEDLE BENT WITHOUT ACTUAL FAILURE (NEEDLES WERE NOT BENT PAST 90 DEG). IT APPEARS THAT THE FAILURE MODE IS RELATED TO TECHNIQUE OF THE END-USER. WHEN THE NEEDLE IS GRIPPED IN THE SWAGED AREA, THE STRESS (LBS. PER SQ. IN.) AT THIS GRIPPED AREA MAY EXCEED THE MAX. STRESS OF THE MATERIAL THUS ALLOWING THE NEEDLE TO BREAK. THE STRESS IS REDUCED WHEN THE NEEDLE IS HELD ABOVE THE SWAGED AREA, THUS ALLOWING THE NEEDLE TO BEND RATHER THAN BREAK. FURTHERMORE, RELEVANT PORTIONS OF THE DHR WERE REVIEWED AND THERE WERE NO CORRESPONDING ISSUES IDENTIFIED DURING MANUFACTURING OR FINAL RELEASE. TO DATE, NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THE REPORTED FINISHED GOOD LOT. ANGIOTECH REFERENCE: COMPLAINT # (B)(4), ITEM # 101-2976, LOOK, #3-0 PLAIN GUT/C6, LOT M329430.

    Description of Event or Problem · 1

    A MEMBER OF DR. (B)(6)'S STAFF REPORTED THAT THE DOCTOR EXPERIENCED TWO (2) INCIDENTS IN WHICH THE NEEDLE BROKE WHILE PERFORMING A DENTAL PROCEDURE USING 3-0 PLAIN GUT SUTURE WITH A C6 NEEDLE ATTACHED. WITH THE FIRST OCCURRENCE, THE NEEDLE BROKE WHILE THE DOCTOR WAS REPOSITIONING THE NEEDLE FOLLOWING THE FIRST BITE/LOOP. THIS DID NOT OCCUR WHILE INSIDE THE PATIENT'S MOUTH. THE SECOND INCIDENT OCCURRED WHILE PIERCING THE PATIENT'S GUM AREA. THE NEEDLE WAS RETRIEVED. HOWEVER, POTENTIAL FOR INJURY EXISTS IF A NEEDLE SHOULD ENTER THE PATIENT'S AIRWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOOK 3-0 PLAIN GUT SUTURE/C6 NEEDLE GAL SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH) 101-2976 M329430

    Patients

    Seq Age Sex Outcome Treatment
    1 Other