BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG

    MDR report key: 8582537 · Received May 6, 2019

    Report

    Report Number
    3003898360-2019-00554
    Event Type
    Malfunction
    Date Received
    May 6, 2019
    Date of Event
    April 30, 2019
    Report Date
    May 2, 2019
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    HAO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). PER DHR THE PRODUCT DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG LOT# 73F1800472 WAS MANUFACTURED ON 06/18/2018 A TOTAL OF(B)(4) PIECES. LOT WAS RELEASED ON 08/03/2018. DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. A FUNCTIONAL TEST WAS CONDUCTED TO TEST THE STRENGTH OF THE RETURNED SAMPLES. EACH DERMAHOOK WAS ATTACHED TO A FORCE GAUGE VIA THE T HERMOPLASTIC ELASTOMER (TPE) BAND AND STRETCHED TO MEASURE THE AMOUNT OF FORCE ON THE BAND. THE TESTED DERMAHOOKS YIELDED THE FOLLOWING RESULTS: FIRST REPRESENTATIVE SAMPLE 1ST TPE BAND: 2.91 LB-FORCE WITHOUT BREAKING 2ND TPE BAND: 2.74 LB-FORCE WITHOUT BREAKING 3RD TPE BAND: 2.55 LB-FORCE WITHOUT BREAKING 4TH TPE BAND: 3.51 LB-FORCE WITHOUT BREAKING 5TH TPE BAND: 3.89 LB-FORCE WITHOUT BREAKING 6TH TPE BAND: 3.25 LB-FORCE WITHOUT BREAKING SECOND REPRESENTATIVE SAMPLE 1ST TPE BAND: 3.56 LB-FORCE WITHOUT BREAKING 2ND TPE BAND: 4.11 LB-FORCE WITHOUT BREAKING 3RD TPE BAND: 3.05 LB-FORCE WITHOUT BREAKING 4TH TPE BAND: 2.36 LB-FORCE WITHOUT BREAKING 5TH TPE BAND: 3.77 LB-FORCE WITHOUT BREAKING 6TH TPE BAND: 3.71 LB-FORCE WITHOUT BREAKING THIRD REPRESENTATIVE SAMPLE 1ST TPE BAND: 3.31 LB-FORCE WITHOUT BREAKING 2ND TPE BAND: 4.69 LB-FORCE WITHOUT BREAKING 3RD TPE BAND: 4.55 LB-FORCE WITHOUT BREAKING 4TH TPE BAND: 3.55 LB-FORCE WITHOUT BREAKING 5TH TPE BAND: 3.93 LB-FORCE WITHOUT BREAKING 6TH TPE BAND: 4.14 LB-FORCE WITHOUT BREAKING FOURTH REPRESENTATIVE SAMPLE 1ST TPE BAND: 3.28 LB-FORCE WITHOUT BREAKING 2ND TPE BAND: 3.50 LB-FORCE WITHOUT BREAKING 3RD TPE BAND: 4.36 LB-FORCE WITHOUT BREAKING 4TH TPE BAND: 2.48 LB-FORCE WITHOUT BREAKING 5TH TPE BAND: 2.49 LB-FORCE WITHOUT BREAKING 6TH TPE BAND: 2.63 LB-FORCE WITHOUT BREAKING THE FOLLOWING EQUIPMENT WAS USED DURING TESTING: FORCE GAGE, EQUIPMENT ID: 10122688 / C05262, CALIBRATION DUE: MAY 29, 2020 RULER, EQUIPMENT ID: 10171599 NONE OF THE SAMPLES BROKE DURING TESTING. ACCORDING TO D023656 REV. 01, "THE FORCE REQUIRED TO STRETCH THE BAND 200% SHALL BE BETWEEN 0.64 AND 0.94 LBF" AND "THE FORCE REQUIRED TO STRETCH THE BAND 300% SHALL BE BETWEEN 0.73 AND 1.07 LBF." ALL DERMAHOOKS TESTED MET THE REQUIREMENTS. THE DERMAHOOKS WERE EVEN STRETCHED GREATER THAN 300% AND ALL WERE ABLE TO WITHSTAND AT LEAST 2.36 LB-FORCE WITHOUT BREAKING, WHICH FAR SURPASSES THE REQUIREMENTS. NO FUNCTIONAL ISSUES WERE FOUND WITH THE RETURNED SAMPLES. SPECIFICATIONS PER GRAPHIC 14-2-001470 REV. 01 AND THE DHF FOR THIS PRODUCT, D023656 REV. 01, WERE REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME SINCE NO FUNCTIONAL DEFECTS WERE FOUND WITH THE RETURNED SAMPLES. FOUR REPRESENTATIVE SAMPLES WERE RETURNED. THE ACTUAL SAMPLE WAS NOT RETURNED. THE REPORTED COMPLAINT OF "RUBBER BANDS BREAKING" WAS NOT CONFIRMED BASED UPON THE SAMPLES RECEIVED. FOUR REPRESENTATIVE SAMPLES WERE RETURNED, BUT THE ACTUAL SAMPLE WAS NOT. A FUNCTIONAL TEST WAS CONDUCTED TO TEST THE STRENGTH OF THE RETURNED SAMPLES. THE STRENGTH OF THE TPE BANDS WAS TESTED AGAINST THE DESIGN SPECIFICATIONS AND ALL DERMAHOOKS TESTED FAR SURPASSED THE REQUIREMENT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE DEVICE WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THERE WERE NO FUNCTIONAL ISSUES FOUND WITH THE RETURNED DERMAHOOKS. SINCE ONLY REPRESENTATIVE SAMPLES WERE RETURNED, THE ROOT CAUSE OF THIS COMPLAINT ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DOCTOR USED THE DERMAHOOKS AND THEY SNAPPED. HE TRIED SEVERAL OF THEM AND THEY KEEP SNAPPING.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR USED THE DERMAHOOKS AND THEY SNAPPED. HE TRIED SEVERAL OF THEM AND THEY KEEP SNAPPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377601 DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG INSTRUMENT, SURGICAL, NON-POWE HAO TELEFLEX MEDICAL 73J1800752

    Patients

    Seq Age Sex Outcome Treatment
    1