BEUDAMED
    FDA Adverse Event Other Summary report: N

    MORIA HANNA TREPHINE BLADE 8.0

    MDR report key: 889521 · Received July 5, 2007

    Report

    Report Number
    2529598-2007-00002
    Event Type
    Other
    Date Received
    July 5, 2007
    Date of Event
    April 12, 2007
    Report Date
    July 5, 2007
    Manufacturer
    MORIA S.A.
    Product Code
    HNJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CO EXAMINED THE BLADE AND FOUND THAT IT DID NOT HAVE A BURR ON IT. BUT IT WAS CORRODED AND BROKEN. SEE EXHIBIT 2 (PHOTOS OF THE BLADE). AS PART OF ITS NORMAL MFG PROCESS, CO CONDUCTS MULTIPLE QUALITY CHECKS IN ANOTHER COUNTRY (WHERE ITS PRODUCT ARE MFG) AND IN THE US (WHERE PRODUCTS ARE PACKAGED AND DISTRIBUTED) BEFORE SHIPPING ITS PRODUCT TO CUSTOMERS. THE REPORTED DEFECTS WOULD HAVE BEEN CAUGHT BY THE QUALITY CHECKS. IN ANY CASE, THE BLADE IN QUESTION EVIDENCED SUBSTANTIAL USE. THUS, IT IS NOT POSSIBLE THAT THIS BLADE WAS SHIPPED TO THE CUSTOMER IN A BROKEN, CORRODED FORM. CO ALSO HAS NO RECORD OF ANY CUSTOMERS, INCLUDING THE MEDICAL CENTER, COMPLAINING ABOUT RECEIVING TREPHINE BLADES IN SUCH CONDITION (NOTE: THIS PRODUCT HAS BEEN SOLD SINCE 1990). THE MEDICAL CENTER BOUGHT THE PUNCH AND THE ACCOMPANYING TREPHINE DONOR WELL IN JUNE OF 1998. SEE EXHIBIT 3 (INVOICE DATED 6/18/1998). THE INSTRUCTIONS FOR THE USE AND MAINTENANCE OF THE PUNCH THAT CO SUPPLIED TO PURCHASERS IN 1998 STATE THAT THE TREPHINE DONOR WELL SHOULD BE REPLACED APPROX EVERY 15 TO 20 USES. SEE EXHIBIT 4 (INSTRUCTION SHEET INCLUDED WITH PRODUCT PACKAGING). CO SUPPLIED TWO REPLACEMENT DONOR WELLS WITH THE MEDICAL CENTER'S ORIGINAL PURCHASE IN JUNE 1998, AND THE MEDICAL CENTER PURCHASED AN ADDITIONAL DONOR WELL FROM CO IN MAY OF 1999. MORIA HAS NO RECORD OF THE MEDICAL CENTER PURCHASING ANY OTHER REPLACEMENT DONOR WELLS FROM MORIA SINCE 1999, AND CO HAS NO RECORD OF EVER SERVICING THE PUNCH. IT IS LIKELY THAT THE CONDITION OF THE BLADE WAS RESULT OF THE DONOR WELL NOT BEING REPLACED AFTER 15 TO 20 USES. ACCORDING TO THE MEDICAL CENTER, THE "TISSUE BECAME INCARCERATED IN THE BLADE DEFECT WITH IMMEDIATE LOSS OF SUCTION, WHICH CAUSED THE GRAFT TO EXPERIENCE THE SOFT CONTACT LENS 'SHRIVEL.'". SEE EXHIBIT 1. WHEN USING THE PUNCH, SUCTION IS MAINTAINED BY SYRINGE PRESSURE APPLIED BY A SURGICAL ASSISTANT DURING THE FEW SECONDS THE CORNEAL TISSUE IS PUNCHED. THE BLADE DOES NOT AFFECT THE SUCTION AND THEREFORE, COULD NOT CAUSE A LOSS OF SUCTION, EVEN IF THE BLADE HAD A DEFECT. HOWEVER, A GRAFT CAN BE "FLIPPED." OR TURNED UPSIDE DOWN, IF SUCTION IS LOST DURING THE PUNCH PROCESS. THE MEDICAL CENTER ALSO CLAIMED THAT "THE LEG OF THE PERIPHERAL DONOR IS LABELED WITH AN 'L' WHICH HELPS DETERMINE IF THE GRAFT FLIPS. UNFORTUNATELY, THE 'L' WAS CUTT OFF BY THE SMALLER THAN USUAL PUNCH SIZE." SEE EXHIBIT 1. THIS RESULT WAS NOT CAUSED BY A DEFECT IN THE PUNCH. THE SIZE OF THE PUNCHED TISSUE IS DETERMINED BY THE TREPHINE BLADE DIAMETER, WHICH IS CHOSEN BY THE SURGEON. IF THE SURGEON PERFORMING THE PROCEDURE IN QUESTION HAD PLACED THE 'L' INSIDE THE PORTION OF TISSUE THAT WILL BE USED AND NOT ON THE TISSUE THAT IS DISCARDED, THE 'L' WOULD NOT HAE BEEN CUTT OFF. ALSO, AS STATED ABOVE, THE LOSS OF THE SUCTION ALONE COULD HAVE CAUSED THE TISSUE TO FLIP OVER. AS A RESULT OF THE 'L' BEING CUTT OFF, THE MEDICAL CENTER STATED THAT THERE WAS A 50/50 CHANCE THAT THE GRAFT WAS IMPLANTED UPSIDE DOWN. AGAIN, THIS IS NOT THE RESULT OF AN ALLEGEDLY DEFECTIVE BLADE. IF THE SURGEON DID NOT KNOW WHETHER THE TISSUE WAS UPSIDE DOWN, THE TISSUE SHOULD NOT HAVE BEEN IMPLANTED IN THE PT.

    Description of Event or Problem · 1

    THIS REPORT FOLLOWS UP ON A MEDICAL DEVICE REPORT (UF/IMPORTER REPORT) DATED 4/19/2007 SUBMITTED. A COPY OF THE MEDICAL CENTER'S REPORT IS ATTACHED AS EXHIBIT 1. THE MEDICAL CENTER REPORTED A PROBLEM WITH THE TREPHINE BLADE CONTAINED WITHIN THE TREPHINE DONOR WELL, WHICH IS PART OF THE HANNA TREPHINE DONOR PUNCH ("THE PUNCH"). THE PUNCH IS A MEDICAL DEVICE THAT CUTS OUT OR "PUNCHES" CORNEAL DONOR TISSUE USED IN CORNEA TRANSPLANTS. THIS DEVICE AND ITS PARTS (SUCH AS THE DONOR WELL) ARE MFG AND DISTRIBUTED BY THE CO. THE MEDICAL CENTER'S REPORT ARISES OUT OF THE TREATMENT OF A PT AT THE MEDICAL CENTER WHO UNDERWENT A RIGHT CORNEAL ENDOTHELIAL CELL TRANSPLANTATION ON A WEEK EARLIER. SEE EXHIBIT 1. THE MEDICAL CENTER USED THE PUNCH TO EXTRACT THE DONOR CORNEAL TISSUE FOR THIS PROCEDURE. THE PUNCH WAS NOT USED ON THE PT DIRECTLY. THE MEDICAL CENTER REPORTED THAT THE TREPHINE BLADE THAT PERFORMS THE CUTTING FUNCTION OF THE PUNCH HAD A BURR ON IT THAT ALLEGEDLY CAUSED PROBLEMS IN THE EXTRACTION OF THE CORNEAL TISSUE FROM THE DONOR CORNEA. DESPITE THESE PROBLEMS, THE SURGEON PROCEEDED TO IMPLANT THE DONOR TISSUE IN THE PT'S EYE. AT THE TIME OF THE REPORT, IT WAS UNCERTAIN WHETHER THE PT SUFFERED ANY INJURY FROM THE IMPLANTATION OF THE DONOR TISSUE. CO HAS HAD NO ACCESS TO THE PT'S MEDICAL RECORDS OR THE SURGEON'S NOTES, AND THEREFORE CANNOT VERIFY THE DESCRIPTION OF EVENTS PROVIDED IN THE MEDICAL CENTER'S REPORT OR WHETHER THIS INCIDENT CONSTITUTED A REPORTABLE EVENT. THE MEDICAL CENTER RETURNED THE DISPOSABLE BLADE TO CI IN JUNE OF 2007 FOR AN EVAL. THE BLADE WAS NOT RETURNED IN ITS ORIGINAL PACKAGING, AND IT HAD NOT BEEN CLEANED BECAUSE THERE WAS STILL DEBRIS ON THE BLADE. THE MEDICAL CENTER DID NOT RETURN THE PUNCH, AND MORIA WAS NOT ABLE TO EVALUATE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MORIA HANNA TREPHINE BLADE 8.0 CORNEA-SCLERA PUNCH/BLADE HNJ MORIA S.A. 17171E LAMTRE253

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other