BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO QUICKANCHOR PLUS PRELOADED WITH 4/0 ETHIBOND SUTURE AND C-1 NEEDLES

    MDR report key: 6979615 · Received October 26, 2017

    Report

    Report Number
    1221934-2017-10607
    Event Type
    Malfunction
    Date Received
    October 26, 2017
    Date of Event
    July 17, 2017
    Report Date
    August 24, 2017
    Manufacturer
    DEPUY MITEK
    Product Code
    HWC
    PMA / PMN Number
    K024115
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE COMPLAINT DEVICE IS NOT AVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT CANNOT BE CONFIRMED. ADDITIONAL INFORMATION WAS PROVIDED AND THE USER MISHANDLED THE DEVICE PRIOR TO USE RESULTING IN THE DEVICE MISFIRING IN THE PATIENT. ALTHOUGH THE DEVICE IS NOT AVAILABLE FOR EVALUATION, THIS FAILURE COULD BE ATTRIBUTED TO USER MISUSE. DHR REVIEW INDICATED THAT THESE BATCH OF DEVICES WERE PROCESSED WITHOUT INCIDENT THEREFORE, THERE IS NO EVIDENCE OF MANUFACTURING ANOMALIES ON THE RECORDS REVIEWED. FURTHER, A REVIEW INTO THE DEPUY MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, SHOULD ANY NEW INFORMATION BE PROVIDED IN THE FUTURE, THIS FILE WILL BE RE-OPENED AND A THOROUGH INVESTIGATION WILL BE PERFORMED. DEPUY MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. (B)(4). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THIS ISSUE WAS FORWARDED VIA EMAIL TO DEPUY QUALITY DEPARTMENT FROM (B)(6). MITEK ANCHOR (212866) WAS DISMANTLED TO COUNT NEEDLES. ANCHOR CAME OFF AND WAS MANUALLY RELOADED. MISFIRED INTO DISTAL PHALANX REQUIRING TO BE FORCIBLY PUSHED. REPAIR COMPROMISED WITH POTENTIAL RISK OF PULL THROUGH. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE CUSTOMER ON (B)(6) 2017. I HAVE CONTACTED THE GOVERNANCE LEAD FOR THE DIRECTORATE WHERE THIS INCIDENT TOOK PLACE AND THEY HAVE INVESTIGATED AND PROVIDED THE FOLLOWING INFORMATION. ¿THIS INCIDENT HAPPENED NOT AS A RESULT OF THE MITEK BEING FAULTY BUT BECAUSE THE NURSE TOOK IT APART TO COUNT THE NEEDLES AND THEN IT WOULDN¿T FIRE PROPERLY. THE REP HAS SINCE BEEN INTO THEATRES AND SOME TRAINING HAS TAKEN PLACE. THIS AROSE AS A RESULT OF A RECENT INCIDENT WHEN A NURSE DID NOT REALISE THERE WERE 2 NEEDLES IN THE MITEK AND THIS RESULTED IN A LOST NEEDLE DURING SURGERY. SOME NURSES HAVE SINCE BEEN OPENING THE EQUIPMENT TO CHECK THE NEEDLES AND THIS CAUSES ISSUES WITH THE EQUIPMENT WORKING PROPERLY. THE NURSES HAVE NOW REVERTED BACK TO NOT OPENING THE MITEK TO CHECK NEEDLES PRIOR TO USE.¿ ADDITIONAL INFORMATION VIA EMAIL FROM THE CUSTOMER ON (B)(6) 2017. MY QUESTION IS NOW THE ISSUE WITH THE ¿LOST¿ NEEDLE. THE ORIGINAL DESCRIPTION STATED THE NEEDLE WAS MANUALLY RELOADED. THIS WAS NOT LOST IN THE PATIENT, CORRECT? I HAVE CHECKED WITH DIRECTORATE AND THEY HAVE CONFIRMED THAT THIS WAS A DIFFERENT PATIENT AND THE NEEDLE WAS NOT IN THIS PREVIOUS PATIENT EITHER, BUT THEY WERE X-RAYED TO CONFIRM AS PER POLICY. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE AFFILIATE ON 9-18-2017. THE INCIDENT REGARDING THE MISSING NEEDLE WAS RECORDED ON OUR DATABASE AND AN INVESTIGATION UNDERTAKEN. THERE WAS NO COMPLAINT RECEIVED. THE PATIENT WAS XRAYED AS PER POLICY AND STAFF REMINDED TO ADHERE TO POLICY FOR CHECKING NEEDLES AND SWABS. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE AFFILIATE ON (B)(6) 2017. THE FIRST INCIDENT WAS IN (B)(6) 2017 AND THERE WAS NO ISSUE WITH THE MITEK. THE NURSES DIDN¿T COUNT THE NEEDLES CORRECTLY AND A NEEDLE WAS LOST. ALL APPROPRIATE ACTION WAS TAKEN AND NO HARM TO PATIENT. FOLLOWING THIS A DECISION WAS MADE TO OPEN THE MITEK PRIOR TO SURGERY TO COUNT THE NEEDLES. THE PACKAGING DOES NOT INDICATE TO SCRUB STAFF HOW MANY NEEDLES ARE INSIDE. UNFORTUNATELY THIS WAS THE CAUSE OF THE SECOND INCIDENT AND THE MITEK DID NOT FIRE. HOWEVER NO HARM TO PATIENT. WE HAVE SINCE AMENDED PRACTICE AGAIN AND STAFF DO NOT OPEN MITEK. YES, THEY THINK IT WAS A MITEK NEEDLE ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE AFFILIATE ON (B)(6) 2017. ¿THE DE-TENSIONING AND MISFIRING RESULTED IN THE ANCHOR LYING OBLIQUELY WITHIN THE TRACT AND WAS PROUD OF THE DISTAL PHALANX. IT HAD TO BE FORCIBLY PUSHED INTO THIS SMALL BONE. DESPITE THIS, THE HOLD WAS SOUND ON TUGGING OF THE ETHIBOND SUTURE ATTACHED TO THE ANCHOR. THE REPAIR RELIES ON THE ANCHOR REMAINING IN THE BONE DURING THE SUBSEQUENT EARLY MOBILISATION REGIMEN. A MISALIGNED ANCHOR WITHIN DAMAGED CORTICAL BONE HAD A POTENTIAL RISK OF PULLING OUT THUS ¿COMPROMISING¿ THE REPAIR. I FELT THAT THE TUG TEST AND EPITENDINOUS REINFORCING SUTURES STILL ALLOWED THE USE OF THE ANCHOR. I WOULD BE HAPPY FOR THIS IS DESCRIBED AS A ¿NEAR MISS¿ IF THIS HELPS CLARIFY MATTERS WITH THE COMPANY. THIS PATIENT HAS BEEN FOLLOWED UP IN OUTPATIENT SINCE AND IS DOING VERY WELL SO FAR.¿ I TRUST THIS WILL ANSWER ANY OUTSTANDING QUERIES AS I AM NOT SURE WE CAN PROVIDE ANY FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758626 MICRO QUICKANCHOR PLUS PRELOADED WITH 4/0 ETHIBOND SUTURE AND C-1 NEEDLES SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE HWC DEPUY MITEK L272592

    Patients

    Seq Age Sex Outcome Treatment
    1