BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROQA+W/#4OC(C1)

    MDR report key: 10408439 · Received August 14, 2020

    Report

    Report Number
    1221934-2020-02088
    Event Type
    Injury
    Date Received
    August 14, 2020
    Date of Event
    July 22, 2020
    Report Date
    July 29, 2020
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HWC
    UDI-DI
    10886705001873
    PMA / PMN Number
    K080352
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, 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. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION PROVIDED, IT WAS REPORTED VIA COMPLAINT SUBMISSION TOOL THAT DURING A HAND SURGERY, A MICRO QUICK ANCHOR PLUS #4-0 ORTHOCORD SUTURE (C-1 NEEDLE) WAS USED. THE ANCHOR WENT IN WITH NO PROBLEM & SEATED WELL. SURGEON TESTED IT BY PULLING ON THE SUTURE ENDS A COUPLE OF TIMES AND IT WAS SOLID. HE THEN STARTED USING THE SUTURE (THAT WAS ATTACHED TO THE ANCHOR) TO SUTURE THE TENDON - WHEN THE SUTURE WAS GLIDING THROUGH THE ANCHOR IT SNAPPED. THE AREA THAT BROKE WAS A PORTION OF THE SUTURE THAT HADN¿T BEEN USED YET - IE HADN¿T BEEN PASSED THROUGH TENDON. HE COULD NOT GET THE ANCHOR OUT BECAUSE IT WAS PROPERLY SEATED ALREADY. THERE IS INSUFFICIENT SPACE IN THE DISTAL PHALANX AT THAT LOCATION TO INSERT A SECOND ANCHOR SO THE REPAIR WAS PERFORMED WITH SUTURING TO PREVIOUS TENDON END WITHOUT ANCHORING TO BONE. IT SIGNIFICANTLY AFFECTED THE STRENGTH OF REPAIR. IMPLANT WAS LEFT INSIDE AND THERE WAS A DELAY OF 30 MINUTES. THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. HOWEVER, A PHOTO WAS PROVIDED. UPON VISUAL INSPECTION OF THE PHOTO, ONLY THE LABEL OF DEVICE WAS OBSERVED. THE PHOTO DOES NOT PROVIDE ENOUGH EVIDENCE THE REPORTED FAILURE, THEREFORE, THE COMPLAINT REPORTED WAS NOT CONFIRMED. SINCE THE COMPLAINT DEVICE REMAINS IMPLANTED, WE CANNOT DETERMINE A SPECIFIC ROOT CAUSE FOR THE REPORTED ISSUE. THE POSSIBLE ROOT CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO HIGH TENSION APPLIED TO THE SUTURE MATERIAL OR ROUGH EDGES ON THE ANCHOR. HOWEVER, THIS CANNOT BE CONCLUSIVE DETERMINED. A DEVICE HISTORY RECORD REVIEW OF LOT NUMBER L736668 WAS PERFORMED, THERE WAS NOT EVIDENCE OF COMPLAINTS RELATED WITH THIS LOT NUMBER. THE DHR REVIEW INDICATED THAT THIS BATCH OF (B)(4) DEVICES WERE PROCESSED WITHOUT INCIDENT, THEREFORE, THERE IS NO EVIDENCE OF MANUFACTURING ANOMALIES ON THE RECORDS REVIEWED. 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 Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA COMPLAINT SUBMISSION TOOL THAT DURING A HAND SURGERY, A MICRO QUICKANCHOR PLUS #4-0 ORTHOCORD SUTURE (C-1 NEEDLE) WAS USED. THE ANCHOR WENT IN WITH NO PROBLEM & SEATED WELL. SURGEON TESTED IT BY PULLING ON THE SUTURE ENDS A COUPLE OF TIMES AND IT WAS SOLID. HE THEN STARTED USING THE SUTURE (THAT WAS ATTACHED TO THE ANCHOR) TO SUTURE THE TENDON - WHEN THE SUTURE WAS GLIDING THROUGH THE ANCHOR IT SNAPPED. THE AREA THAT BROKE WAS A PORTION OF THE SUTURE THAT HADN'T BEEN USED YET - IE HADN'T BEEN PASSED THROUGH TENDON. HE COULD NOT GET THE ANCHOR OUT BECAUSE IT WAS PROPERLY SEATED ALREADY. THERE IS INSUFFICIENT SPACE IN THE DISTAL PHALANX AT THAT LOCATION TO INSERT A SECOND ANCHOR SO THE REPAIR WAS PERFORMED WITH SUTURING TO PREVIOUS TENDON END WITHOUT ANCHORING TO BONE. IT SIGNIFICANTLY AFFECTED THE STRENGTH OF REPAIR. IMPLANT WAS LEFT INSITU AND THERE WAS A DELAY OF 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871382 MICROQA+W/#4OC(C1) SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE HWC DEPUY MITEK LLC US 212041 L736668 10886705001873

    Patients

    Seq Age Sex Outcome Treatment
    1