BEUDAMED
    FDA Adverse Event Other Summary report: N

    GUIDE PIN, 2.4MM DRILL TIP

    MDR report key: 1316673 · Received February 18, 2009

    Report

    Report Number
    1220246-2009-00016
    Event Type
    Other
    Date Received
    February 18, 2009
    Date of Event
    January 9, 2009
    Report Date
    January 29, 2009
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REQUESTED FOR EVALUATION BUT WAS NOT RETURNED, THEREFORE, THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. THE LOT NUMBER WAS REQUESTED BUT NOT PROVIDED, THEREFORE, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED AND MANUFACTURING DATE COULD NOT BE DETERMINED. BASED ON THE INFORMATION PROVIDED, IT IS UNCERTAIN WHETHER THIS EVENT RESULTED FROM SURGICAL TECHNIQUE OR PATIENT NON-COMPLIANCE WITH THE POST-OP PROTOCOL. IF ADDITIONAL RELEVANT PATIENT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A POST-OP OFFICE VISIT FOR AN AC RECONSTRUCTION OF THE LEFT SHOULDER, AN X-RAY REVEALED THE PATIENT'S CORACOID BONE WAS FRACTURED AND DISPLACED. PER THE REPORTER, THE ONLY REPORTED SURGICAL ANOMALY WAS THAT THE SURGEON MISSED HIS MARK DURING THE INITIAL AC REPAIR AND HAD TO RE-DRILL, MAKING AN EXTRA HOLE IN THE BONE; THIS MAY HAVE CONTRIBUTED TO THE FRACTURE. DATE OF INITIAL SURGERY WAS (B)(6) 2009. FOLLOW-UP WITH THE SURGEONS FACILITY PROVIDED INFORMATION THAT STATES THE DEVICE POSITION WAS ASSESSED AND FOUND SATISFACTORY. THE PATIENT HAS BEEN REFERRED TO A DIFFERENT SURGEON FOR ANY FOLLOW UP IF NEEDED. NO FURTHER PATIENT OUTCOME INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO MULTIPLE FOLLOW-UP COMMUNICATION ATTEMPTS WITH THE PHYSICIAN'S OFFICE. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FOR THIS EVENT. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDE PIN, 2.4MM DRILL TIP LXH ARTHREX, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other INFORMATION REQUESTED BUT NOT PROVIDED