BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5 HEALIX ADVANCE PEEK W/CORD

    MDR report key: 7680051 · Received July 11, 2018

    Report

    Report Number
    1221934-2018-53435
    Event Type
    Malfunction
    Date Received
    July 11, 2018
    Date of Event
    June 18, 2018
    Report Date
    June 18, 2018
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HWC
    UDI-DI
    10886705021390
    PMA / PMN Number
    K120449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT:# (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: (B)(4). THE EXPIRATION DATE IS NOT CURRENTLY AVAILABLE.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE EVALUATION STATEMENT: THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT WAS DISCARDED BY THE CUSTOMER, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT CANNOT BE CONFIRMED. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PRODUCT CODE 222303-LOT #L705618 COMBINATION AND NO NON-CONFORMANCES WERE IDENTIFIED. NO FURTHER INFORMATION REGARDING THE TECHNIQUE OR INSTRUMENTS USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. IF ANY ADDITIONAL INFORMATION IS OBTAINED, THIS COMPLAINT WILL BE RE-OPENED TO CAPTURE THAT INFORMATION. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES 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. ADDITIONAL INFORMATION:: THE EXPIRATION DATE WAS UNKNOWN IN THE INITIAL MEDWATCH REPORT. THE EXPIRATION DATE (FEB 28, 2021) AND THE UNIQUE IDENTIFIER (UDI) HAS BEEN UPDATED ACCORDINGLY. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ANCHOR WAS IMPLANTED IN SOFT BONE, PULLED OUT, AS SCRUB NURSE WAS TRYING TO PUT ANCHOR BACK ON INSERTER SHAFT, THE ANCHOR SPLIT MAKING IT UNABLE TO BE IMPLANTED. ACTION TAKEN TO MANAGE THE PROBLEM: USED 222305 5.5MM ANCHOR. 1 MINUTE DELAY TO PROCEDURE. NO AE TO PATIENT. ADDITIONAL INFORMATION RECEIVED ON 10/2/2018. THE ISSUE WAS DETECTED AT THE TIME OF INCIDENT. THE FAILURE WAS ANCHOR BROKE. THE RESULTING SURGICAL DELAY WAS ONE MINUTE. THE PROCEDURE WAS COMPLETED. THE REVISION PROCEDURE WAS UNSURE. THERE WAS NO ANY PATIENT IMPACT. THE PATIENT'S BONE QUALITY WAS POOR. IT WAS NOT THE SAME BONE HOLE USED TO COMPLETE THE PROCEDURE. THE IMPLANT WAS REMOVED. MINIMAL FORCE WAS USED WHEN THE ANCHOR PULLED OUT. THE ANCHOR DID NOT REMAIN ON THE INSERTER AFTER REMOVAL FROM THE CANNULA. THE SURGEON PULL ONLY WHILE REMOVING. THE SUTURE WAS WRAP AROUND THE HANDLE OR DRIVER. THE SURGEON DID NOT GRASP THE SUTURE DURING INSERTION. THE SURGEON DID NOT GRASP THE SUTURE DURING REMOVAL. THE SURGEON USED APPROPRIATE DOWNWARD FORCE WITH DRIVING ANCHOR IN. ALL SUTURE LIMBS WERE TESTED TO VERIFY THE REPAIR. FOUR STRANDS, ORTHOCORD SUTURE WERE USED.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4). (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ANCHOR WAS IMPLANTED IN SOFT BONE, PULLED OUT, AS SCRUB NURSE WAS TRYING TO PUT ANCHOR BACK ON INSERTER SHAFT, THE ANCHOR SPLIT MAKING IT UNABLE TO BE IMPLANTED. ACTION TAKEN TO MANAGE THE PROBLEM: USED 222305 5.5 MM ANCHOR. ONE MINUTE DELAY TO PROCEDURE. NO AE TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519355 4.5 HEALIX ADVANCE PEEK W/CORD SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE HWC DEPUY MITEK LLC US L705618 10886705021390

    Patients

    Seq Age Sex Outcome Treatment
    1