BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE KIT FOR 1.8MM SHOULDER Q-FIX

    MDR report key: 19950177 · Received August 9, 2024

    Report

    Report Number
    3006524618-2024-00311
    Event Type
    Injury
    Date Received
    August 9, 2024
    Date of Event
    July 19, 2024
    Report Date
    September 18, 2024
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    LXH
    UDI-DI
    00885556724613
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE (B)(4). H10: B7: BONE QUALITY ADDED. INTERNAL COMPLAINT REFERENCE (B)(4). H11: H1: UPDATED TO SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: CASE-(B)(4).

    Additional Manufacturer Narrative · 0

    H3, H6: A DEVICE DEFICIENCY WAS NOT IDENTIFIED, AND THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND NO SIMILAR REPORTED EVENTS. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. THE INSTRUCTIONS FOR USE WERE REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. A CLINICAL REVIEW STATES THE ADVERSE EVENT WAS LIKELY PROCEDURE RELATED AND THE DEVICE HAD NO INFLUENCE ON THE EVENT. THE BROKEN DRILL TIP FROM THE SHOULDER Q-FIX WAS MANUFACTURED AND INTENDED AS EXTERNALLY COMMUNICATING DEVICES AND IT HAS NOT BEEN APPROVED FOR LONG TERM INTERNAL TISSUE EXPOSURE AND LONG-TERM IMPLANTATION DATA IS NOT AVAILABLE. THE DRILL TIP WAS RETAINED IN THE SUPERIOR POLE OF THE PATELLA; THEREFORE, MICRO-MOTION AND MIGRATION IS UNLIKELY. HOWEVER, WE CANNOT MAKE ANY CONCLUSIONS ON THE IMPACT OF THE NON-IMPLANTABLE FOREIGN BODY. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. IF ANY ADDITIONAL INFORMATION RELATED TO THIS EVENT IS RECEIVED IN THE FUTURE, THIS INVESTIGATION WILL BE REOPENED FOR FURTHER ASSESSMENT. CORRECTED DATA: H6: HEALTH EFFECT CLINICAL AND IMPACT CODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A MPFL RECONSTRUCTION, WHEN SURGEON WAS DRILLING HARD BONE IN THE SUPERIOR PATELLA, THE TIP OF THE DRILL FROM THE KIT FOR SHOULDER Q-FIX SNAPPED INSIDE THE BONE. THE TIP WAS LEFT IN SITU. AFTER THE RECONSTRUCTION, A SCOPE WAS PERFORMED BUT DRILL WAS NOT IN THE JOINT. AN II IMAGE SHOWED THE BROKEN DRILL BIT IN THE SUPERIOR POLE OF THE PATELLA. SURGERY WAS COMPLETED WITH THE SAME DEVICE. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2201032 DISPOSABLE KIT FOR 1.8MM SHOULDER Q-FIX ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHROCARE CORPORATION 2143537 00885556724613

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown