BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5MM HEALX ADV SP PEEK ANCHOR

    MDR report key: 9723355 · Received February 18, 2020

    Report

    Report Number
    1221934-2020-00592
    Event Type
    Malfunction
    Date Received
    February 18, 2020
    Date of Event
    February 6, 2020
    Report Date
    February 6, 2020
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    MAI
    UDI-DI
    10886705030606
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY: THE DEVICE WAS RECEIVED, AND AN EVALUATION WAS PERFORMED. VISUAL INSPECTION REVEALED THAT THE AWL TIP (DISTAL TIP) OF THE DEVICE WAS BENT. NO OTHER DAMAGE WAS OBSERVED ON THE DEVICE. THUS, THE COMPLAINT IS CONFIRMED. EXCESSIVE FORCE ON THE TIP DURING USAGE MIGHT HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. AN MRE WAS PERFORMED FOR THE FINISHED DEVICE PART# 222425 AND LOT# 6L32115 AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. DEVICE HISTORY LOT:DEVICE HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED ON PRODUCT CODE: 222425 WITH LOT NUMBER: 6L32115; AND DETERMINED THAT THERE WERE NO ANOMALIES OR DISCREPANCIES RELATED TO THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP VIA EMAIL THAT DURING A SHOULDER ARTHROSCOPY THE 5.5MM HEALX ADV SP PEEK ANCHOR BENT WHEN SURGEON WAS TRYING TO MALLET INTO BONE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182213 5.5MM HEALX ADV SP PEEK ANCHOR SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE MAI MEDOS INTERNATIONAL SàRL 222425 6L32115 10886705030606

    Patients

    Seq Age Sex Outcome Treatment
    1