BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8582511 · Received May 6, 2019

    Report

    Report Number
    3003898360-2019-00553
    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
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PER DHR THE PRODUCT DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG LOT# 73K1800241 WAS MANUFACTURED ON 10/15/2018 A TOTAL OF (B)(4)PIECES. LOT WAS RELEASED ON 10/22/2018. DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. THE CUSTOMER RETURNED FOUR REPRESENTATIVE SAMPLES OF 382805 DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG FOR INVESTIGATION. THE ACTUAL SAMPLE WAS NOT RETURNED. THE RETURNED SAMPLES WERE VISUALLY EXAMINED WITH AND WITHOUT MAGNIFICATION. VISUAL EXAMINATION REVEALED THAT THREE OF THE REPRESENTATIVE SAMPLES APPEAR TYPICAL, BUT ONE OF THE REPRESENTATIVE SAMPLES HAD TWO OF THE BANDS OVERLAPPING. A DEFECT WAS OBSERVED IN ONE OF THE RETURNED REPRESENTATIVE SAMPLES AS TWO OF THE BANDS WERE OVERLAPPING. PRODUCT DRAWING 14-2-001470 REV. 03 IDENTIFIES THAT THE BANDS ARE NOT TO OVERLAP. THE SAMPLE WAS SENT TO THE MANUFACTURING SITE FOR DIMENSIONAL INSPECTION AND IT WAS CONFIRMED THAT THE SAMPLES WERE WITHIN THE DEFINED SPECIFICATIONS PER DRAWING 150014505 REV 00. A FUNCTIONAL TEST WAS CONDUCTED TO TEST THE STRENGTH OF THREE OF THE REPRESENTATIVE SAMPLES. EACH DERMAHOOK WAS ATTACHED TO A FORCE GAUGE VIA THE THERMOPLASTIC 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: 3.51 LB-FORCE WITHOUT BREAKING 2ND TPE BAND: 3.54 LB-FORCE WITHOUT BREAKING 3RD TPE BAND: 3.66 LB-FORCE WITHOUT BREAKING 4TH TPE BAND: 2.24 LB-FORCE WITHOUT BREAKING 5TH TPE BAND: 2.35 LB-FORCE WITHOUT BREAKING 6TH TPE BAND: 3.30 LB-FORCE WITHOUT BREAKING SECOND REPRESENTATIVE SAMPLE 1ST TPE BAND: 2.82 LB-FORCE WITHOUT BREAKING 2ND TPE BAND: 3.42 LB-FORCE WITHOUT BREAKING 3RD TPE BAND: 2.65 LB-FORCE WITHOUT BREAKING 4TH TPE BAND: 2.55 LB-FORCE WITHOUT BREAKING 5TH TPE BAND: 3.37 LB-FORCE WITHOUT BREAKING 6TH TPE BAND: 3.77 LB-FORCE WITHOUT BREAKING THIRD REPRESENTATIVE SAMPLE 1ST TPE BAND: 3.26 LB-FORCE WITHOUT BREAKING 2ND TPE BAND: 3.47 LB-FORCE WITHOUT BREAKING 3RD TPE BAND: 3.52 LB-FORCE WITHOUT BREAKING 4TH TPE BAND: 3.61 LB-FORCE WITHOUT BREAKING 5TH TPE BAND: 3.67 LB-FORCE WITHOUT BREAKING 6TH TPE BAND: 3.19 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 2.24 LB-FORCE WITHOUT BREAKING, WHICH FAR SURPASSES THE REQUIREMENTS. NO FUNCTIONAL ISSUES WERE FOUND WITH THE TESTED REPRESENTATIVE SAMPLES. SPECIFICATIONS PER GRAPHIC 14-2-001470 REV. 03 AND 150014505 REV. 00 WERE REVIEWED AS PART OF THIS COMPLAINT INVESTIGATION. THE TRACEABILITY MATRIX FOR THIS PRODUCT, D023656 REV. 01, WAS REVIEWED AS PART OF THIS COMPLAINT INVESTIGATION. GS-0116TEC REV. 12 AND QIP-0031TEC REV. 28 WERE REVIEWED AS PART OF THIS COMPLAINT INVESTIGATION TO CONFIRM THAT THE BANDS ARE ASSEMBLED AND INSPECTED SUCH THAT THEY DO NOT OVERLAP. THE REPORTED COMPLAINT OF "RUBBER BANDS BREAKING" WAS NOT CONFIRMED BASED UPON THE SAMPLE RECEIVED. FOUR REPRESENTATIVE SAMPLES WERE RETURNED. THE ACTUAL SAMPLE WAS NOT RETURNED. A FUNCTIONAL TEST WAS CONDUCTED TO TEST THE STRENGTH OF THREE OF THE RETURNED REPRESENTATIVE SAMPLES. THE STRENGTH OF THE TPE BANDS WAS TESTED AGAINST THE DESIGN SPECIFICATIONS AND ALL DERMAHOOKS TESTED FAR SURPASSED THE REQUIREMENT. THERE WERE NO FUNCTIONAL ISSUES FOUND WITH THE DERMAHOOKS TESTED. SINCE ONLY REPRESENTATIVE SAMPLES WERE RETURNED, THE ROOT CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED WITHOUT THE ACTUAL SAMPLE. HOWEVER, A DEFECT WAS OBSERVED IN THE FOURTH REPRESENTATIVE SAMPLE AS TWO OF THE BANDS WERE OVERLAPPING. THE SAMPLE WAS SENT TO THE MANUFACTURING SITE FOR DIMENSIONAL INSPECTION AND IT WAS CONFIRMED THAT THE SAMPLES WERE WITHIN SPECIFICATION. THE BANDS ARE INSPECTED DURING MANUFACTURING ASSEMBLY TO ENSURE THAT THEY DO NOT OVERLAP , AND IT IS UNLIKELY THAT THIS DEFECT WAS PRESENT AT THE TIME OF MANUFACTURING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. IT'S POSSIBLE THAT SHIPPING/HANDLING CAUSED THE BANDS TO OVERLAP, BUT THIS COULD NOT BE CONFIRMED. THE SAMPLE WAS REVIEWED WITH A R & D ENGINEER AND IT COULD NOT BE DETERMINED EXACTLY HOW OR WHAT CAUSED THE BANDS TO OVERLAP. THIS IS AN ISOLATED EVENT AND WE WILL CONTINUE TO MONITOR AND TREND ON THIS ISSUE.

    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
    376946 DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG INSTRUMENT, SURGICAL, NON-POWE HAO TELEFLEX MEDICAL 73K1800241

    Patients

    Seq Age Sex Outcome Treatment
    1