MAUDE Adverse Event Report: ARTHREX, INC. RING CURETTE, ANKLE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	AR-8655-14
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (date of birth) 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 for evaluation but was not returned therefore the complainant's event could not be verified.Lot number was not provided so device history record review cannot be performed.The cause of the event could not be determined from the information available and without device evaluation.The complainant's event is typically caused by excessive force or prying/leveraging during use.Device requested but not yet received.
Event or Problem Description
It was reported that an ar-8655-14, straight ring curette for ankle arthroscopy, was being used for an ankle arthroscopy and syndesmosis tight rope procedure.The tip of the curette was broken-off during the curettage stage of the ankle arthroscopy of the talus.Surgeon tried to retrieve the metal device tip by making an extra incision and tried under fluoroscopy to get access to the broken piece but was unable to retrieve it.Device tip was left un-retrieved.Remaining portion was discarded by user facility.Skin was closed and the patient was brought out of the operating room.The procedure was completed successfully.

• Brand Name: RING CURETTE, ANKLE
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6030001
• Report Number: 1220246-2016-00422
• Device Sequence Number: 391143
• Product Code: MDM
• UDI-Device Identifier: 00888867044364
• UDI-Public: 00888867044364
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/22/2016

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-8655-14
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2016
• Initial Report FDA Received Date: 10/14/2016
• 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: 14 YR
• Patient Weight: 91