BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIV L INSERTION INSTRUMENT F/H8.5MM

    MDR report key: 13771040 · Received March 15, 2022

    Report

    Report Number
    2916714-2022-00012
    Event Type
    Injury
    Date Received
    March 15, 2022
    Date of Event
    January 21, 2022
    Report Date
    October 28, 2022
    Manufacturer
    AESCULAP AG
    Product Code
    QLQ
    UDI-DI
    04038653425587
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: VISUAL INVESTIGATION: HERE WE FOUND NO DAMAGES, DEFECTS OR OTHER DEVIATIONS. IN THE NEXT STEP WE TESTED THE GAP BETWEEN THE BLUE RING AND THE OPPOSITE METAL BODY (THE POSITION WHERE, ACCORDING TO THE DESCRIPTION, THE OPERATOR HAS PINCHED THE GLOVE) WITH A FEELER GAUGE SET. WE FOUND A GAP OF 0,22 MM WITH THE INSTRUMENT CORRECTLY CLAMPED/TIGHTENED. AFTER THAT WE MADE A VISUAL/MICROSCOPIC INVESTIGATION OF THE IMPLANT PICK UP INTERFACE. HERE WE FOUND NO DEFECTS LIKE UNUSUAL WEAR OR DEFORMED PINS. AT LAST WE CHECKED THE BALL SCREWS UNDER THE ROTATION SLEEVE. HERE WE FOUND ALL FIXATION POINTS (WELDING POINTS) BROKEN. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS (DHR) HAVE BEEN CHECKED FOR ALL LEADING DEVICE(S) LOT NUMBERS AND THE PRODUCTS FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. THERE ARE NO SIMILAR COMPLAINTS AGAINST THE SAME LOT NUMBER(S) WITH THIS ERROR PATTERN. THE REVIEW OF RISK ASSESSMENT REVEALED THAT THE OVERALL RISK LEVEL (PROBABILITY OF OCCURRENCE 1(5)) ACCORDING TO DIN EN ISO 14971 IS STILL ACCEPTABLE. EXPLANATION AND RATIONALE: THE DEFECT ITSELF THAT WAS THE SUBJECT OF THE COMPLAINT COULD NOT BE READJUSTED AND COULD NOT BE CONFIRMED. THE CAUSE OF THE JAMMED GLOVE WAS PROBABLY A NOT FULLY TIGHTENED ROTATION SLEEVE. WITH THIS SLEEVE TIGHTENED NOT CORRECT/FULLY, IT IS POSSIBLE TO PULL BACK THE SLEEVE, SO THAT A GREATER GAP BETWEEN THE BLUE RING AND THE METAL BODY ARISE. IN THIS STATE IT IS POSSIBLE TO GET THE GLOVE TRAPPED. THE BROKEN WELD POINTS OF THE BALL SCREW FIXATION HAVE NO INFLUENCE ON THE PROBLEM COMPLAINED ABOUT. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS, THE ROOT CAUSE OF THE PROBLEM CANNOT CLEARLY BE DETERMINED. THERE IS NO INDICATION FOR A MATERIAL OR DESIGN-RELATED FAILURE. A PRODUCT SAFETY CASE (PSC) WAS COMPLETED. THIS CASE WAS EVALUATED WITHIN PSC AND FAILURE CORRESPONDS TO A SEVERITY OF 2(5). ANY ACTION REGARDING CAPA WILL BE ADDRESSED WITH THIS PSC.

    Description of Event or Problem · 0

    IT WAS REPORTED TO AESCULAP INC. THAT A ACTIV L INSERTION INSTRUMENT F/H8.5MM (PART # FW961R) WAS IMPLANTED DURING A PRIMARY PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, DURING THE IMPLANT OF ACTIVL, THE SURGEON'S GLOVE BECAME CAUGHT IN THE ACTIV L INSERTION INSTRUMENT AS HE WAS USING A MALLET TECHNIQUE TO MAKE SURE THE DEVICE WAS PLACED SECURELY. AS HE WAS MALLET-ING THE DEVICE IN PLACE THE GLOVE WAS CAUGHT IN THE BLUE RINGED PORTION OF THE HANDLE (CLOSEST TO THE DOCTOR). AS SUCH THE DOCTOR USED X-RAY, FLUOROSCOPY TO ENSURE THE IMPLANT WAS IN THE CORRECT POSITION. THERE WAS NO BACK UP DEVICE AVAILABLE, BUT THE FLUOROSCOPY FOUND THAT THE DEVICE WAS PLACED IN THE CORRECT LOCATION. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO FURTHER INTRAOPERATIVE EVENTS OR ISSUES. THE SURGEON REPORTED THAT, IN THE FUTURE, HE WILL ALWAYS HAVE TWO OF THESE INSTRUMENTS IN A PROCEDURE IN THE EVENT THAT THIS SHOULD OCCUR AGAIN. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE PATIENT UNDERWENT ADDITIONAL UNEXPECTED DIAGNOSTIC INTERVENTION AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED WHICH REVEALED: THE PIECE OF THE GLOVE FRAGMENT WAS CAUGHT IN THE BLUE RINGED PORTION OF THE DEVICE. THIS BLUE RING PORTION WAS DESCRIBED AS THE COLOR CODED PIECE THAT COVERS THE YELLOW THREADED PORTION OF THE DEVICE. THE SURGEON ONLY HAD ONE ACTIV L INSERTION INSTRUMENT F/H8.5MM INSTRUMENT AS SUCH HE USED FLUOROSCOPY TO ENSURE THE IMPLANT WAS PLACED APPROPRIATELY AS HE WOULD NOT BE ABLE TO USE THE INSERTION INSTRUMENT AGAIN ON THE PATIENT. IT WAS CONFIRMED THAT THE IMPLANT WAS IN THE RIGHT PLACE AND THE SURGERY WAS CONTINUED WITHOUT ANY HARM TO THE PATIENT OR SURGICAL DELAYS. THE MALFUNCTION IS FILED UNDER AIC REFERENCE (B)(4).

    Description of Event or Problem · 0

    INVESTIGATION COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696512 ACTIV L INSERTION INSTRUMENT F/H8.5MM INSTRUMENTS SPINAL MOTION QLQ AESCULAP AG FW961R 52671311 04038653425587

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention