BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGIDFIX FEM 3.3MM S/T XPIN

    MDR report key: 8262239 · Received January 18, 2019

    Report

    Report Number
    1221934-2019-56054
    Event Type
    Malfunction
    Date Received
    January 18, 2019
    Date of Event
    August 27, 2016
    Report Date
    August 27, 2016
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HWC
    UDI-DI
    10886705000890
    PMA / PMN Number
    K010633
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UY
    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. UDI: (B)(4). THIS REPORT IS BEING FILED FROM THE ETQ COMPLAINT MANAGEMENT SYSTEM AS REQUIRED UNDER MITEK'S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS. A CORRECTION IS BEING SUBMITTED DUE TO THE CORRECTION ON UDI AND DEVICE RECEIVE DATE. NO OTHER CHANGES ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. UDI: (B)(4). THE EXP DATE IS CURRENTLY UNAVAILABLE. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. THE REPORTED FAILURE COULD BE CONFIRMED FROM THE VISIBLE MARK ON THE TROCAR WHERE IT HAD COLD WELDED WITH THE SLEEVE. THE PIN WAS RETURNED STUCK TO THE SLEEVE. ADDITIONALLY, THE SIDE PIN OF ONE SLEEVE WAS BROKEN OFF. HISTORICALLY, THIS TYPE OF FAILURE HAS BEEN ATTRIBUTED TO USER TECHNIQUE ISSUE. THE LOCATION OF THE TROCAR INTERLOCKING PINS IS SUPERIOR TO THE MATING PORTION OF THE SLEEVE. IF THE PINS ARE NOT SEATED WITHIN THESE GROVES THEN THE TROCAR IS SPINNING WITHIN THE GUIDE SLEEVE CAUSING ENOUGH HEAT AND FRICTION TO CAUSE THE "WELDING" OF THE TWO PARTS. FURTHER, A REVIEW INTO THE 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, 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. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PRODUCT CODE 210133, LOT 3894948 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. THIS REPORT IS BEING FILED FROM THE ETQ COMPLAINT MANAGEMENT SYSTEM AS REQUIRED UNDER MITEK'S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE, IT WAS OBSERVED THAT TWO METAL PARTS ON THE RIGIDFIX FEM 3.3MM S/T XPIN DEVICE GOT STUCK TOGETHER. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53832 RIGIDFIX FEM 3.3MM S/T XPIN SOFT-TISSUE ANCHOR, BIOABSORBABLE HWC DEPUY MITEK LLC US 3894948 10886705000890

    Patients

    Seq Age Sex Outcome Treatment
    1