BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6526801 · Received April 27, 2017

    Report

    Report Number
    3003898360-2017-00414
    Event Type
    Malfunction
    Date Received
    April 27, 2017
    Date of Event
    March 31, 2017
    Report Date
    April 4, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    HAO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED ONE UNIT OF 382805 DERMAHOOK 1/2 HOOK PKG/BX 6 HKS/PKG FOR INVESTIGATION. ONE THERMOPLASTIC ELASTOMERIC (TPE) BAND WAS RETURNED WITH THE HOOK AND SUTURE. THE RETURNED SAMPLE WAS VISUALLY EXAMINED WITH AND WITHOUT MAGNIFICATION. VISUAL EXAMINATION REVEALED THAT THE TPE BAND WAS BROKEN AT WHAT APPEARS TO BE APPROXIMATELY THE LOCATION WHERE THE SUTURE WAS TIED TO THE BAND. THE SUTURE THREAD AND HOOK WERE STILL ATTACHED TO EACH OTHER BUT NOT TO THE BAND. IF THE SUTURE KNOT IS TIED TOO TIGHT, THIS CAN CAUSE A BREAKAGE IN THE TPE BAND DUE TO THE EXCESS TENSION THAT IS APPLIED. THE RETURNED SAMPLE APPEARS USED AS THERE IS BIOLOGICAL MATERIAL PRESENT ON THE DEVICE. A FUNCTIONAL TEST WAS CONDUCTED ON THE RETURNED SAMPLE. THE BAND WAS ABLE TO BE STRETCHED UP TO SIX TIMES ITS LENGTH WITHOUT SNAPPING. ACCORDING TO DHF D001915 REV. 03, "THE BAND SHALL BE ABLE TO STRETCH AT LEAST TRIPLE OR 300% ITS ORIGINAL LENGTH WITH A FORCE OF 0.90 0.17 LB-FORCE WITHOUT BREAKING." BY BEING ABLE TO BE STRETCHED UP TO SIX TIMES ITS LENGTH WITHOUT BREAKING, THE BAND MEETS THE REQUIREMENT. SINCE THE SUTURE WAS NOT RETURNED ATTACHED TO THE TPE BAND, IT COULD NOT BE CONFIRMED WHETHER OR NOT THE SUTURE WAS TIED TOO TIGHTLY TO THE BAND. HOWEVER , THE BREAK POINT IS CONSISTENT WITH DAMAGE FOUND WHEN THE SUTURE IS TIED TOO TIGHT. THIS COULD BE CAUSED BY APPLYING TOO MUCH FORCE ON THE SUTURE SO THAT THE BAND STARTS TO BULGE OUT OF THE SUTURE AND EVENTUALLY SNAP. SPECIFICATIONS PER GRAPHIC 14-2-001470 REV. 01 AND THE DHF FOR THIS PRODUCT, D001915 REV. 03, WERE REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. ACCORDING TO DHF D001915 REV. 03, "THE BAND SHALL BE ABLE TO STRETCH AT LEAST TRIPLE OR 300% ITS ORIGINAL LENGTH WITH A FORCE OF 0.90 0.17 LB-FORCE WITHOUT BREAKING." THE IFU FOR THIS PRODUCT, 220002750, WAS ALSO REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. THE IFU FOR THIS PRODUCT STATES, "IF THE ELASTIC BAND CONTAINS TEARS, SPLITS OR OTHER DAMAGE, DO NOT USE. DO NOT OVERSTRETCH THE ELASTIC BAND." A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME. THE DEVICE HISTORY RECORD REVIEW SHOWED NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. BASED ON THE CONDITION OF THE SAMPLES RECEIVED AND THE TIME OF DISCOVERY, OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THIS EVENT. THE REPORTED COMPLAINT OF "BROKEN" WAS CONFIRMED BASED UPON THE SAMPLE RECEIVED. ONE TPE BAND WAS RETURNED THAT WAS BROKEN AT APPROXIMATELY THE POINT AT WHICH THE SUTURE WOULD BE TIED TO THE BAND. THE HOOK AND SUTURE WERE ALSO RETURNED, BUT THEY WERE NOT ATTACHED TO THE BAND. FUNCTIONAL TESTING WAS PERFORMED AND IT WAS FOUND THAT THE RETURNED BAND WAS ABLE TO STRETCH UP TO SIX TIMES ITS ORIGINAL LENGTH WITHOUT BREAKING WHICH MEETS THE REQUIREMENT OF BEING ABLE TO STRETCH THREE TIMES ITS LENGTH. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE DEVICE WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. BASED ON THE CONDITION OF THE SAMPLES RECEIVED AND THE TIME OF DISCOVERY, OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THIS EVENT. NO FURTHER ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY REVIEW FOR THE PRODUCT DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG, LOT #73J1600588 INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. THE DEVICE INVESTIGATION REPORT HAS NOT BEEN SUBMITTED AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    THE ELASTIC BROKE IN 2 PIECES DURING USE. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 1

    THE ELASTIC BROKE IN 2 PIECES DURING USE. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307453 DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG INSTRUMENT,SURGICAL,NON-POWERED HAO TELEFLEX MEDICAL 73J1600588

    Patients

    Seq Age Sex Outcome Treatment
    1