MAUDE Adverse Event Report: ARTHREX INC. CURETTE, RING 3.4MM, CUTTING BOTH SIDE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	AR-21020
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device was requested/is expected for evaluation but has not yet been received.The cause of the event could not be determined from the information available and without device evaluation.Device history record review revealed nothing relevant to this event.Complainant's event typically caused by applying excessive leveraging forces.The potential causes of this event are being communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.
Event or Problem Description
It was reported that during an ankle arthroscopic arthrodesis, the ankle was decorticated with a 4mm burr, a 3.5mm full radius resector and ring curettes.During decortication with ring curettes, it was noted that a small fragment of the ring curette broke and ended up in the posterior recess of the ankle.Attempts to retrieve it were unsuccessful; surgeon opted to leave it in instead of possibly causing more harm.Patient will be monitored by surgeon.Patient is a (b)(6) male.

• Brand Name: CURETTE, RING 3.4MM, CUTTING BOTH SIDE
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7422027
• Report Number: 1220246-2018-00125
• Device Sequence Number: 69712
• Product Code: MDM
• UDI-Device Identifier: 00888867026056
• UDI-Public: 00888867026056
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: AR-21020
• Device Lot Number: 78843
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR