MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX CHONDRAL DART, 18MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	AR-4005B-18
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/02/2017
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 for evaluation but fragment was discarded by the customer and remainder of device was left in patient.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.If the device is returned and additional information is obtained, a follow-up report will be submitted.Device history record review revealed nothing relevant to this event.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a case, the surgeon was using chondral darts to fixate a chondral defect.A small piece of the 18 mm arthrex chondral dart, ar-4005b-18, lot: e3329, broke-off during insertion.The fragment was retrieved and discarded.The majority of the implant was purposely left in the patient for additional fixation, as there were enough barbs to provide said fixation.Additional darts were used as prescribed for additional fixation.This did not cause an adverse effect to the patient, and no intervention was necessary.

• Brand Name: ARTHREX CHONDRAL DART, 18MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6680675
• Report Number: 1220246-2017-00238
• Device Sequence Number: 1538625
• Product Code: MAI
• UDI-Device Identifier: 00888867031166
• UDI-Public: 00888867031166
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K082999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 06/30/2017

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 Expiration Date: 04/01/2020
• Device Catalogue Number: AR-4005B-18
• Device Lot Number: E3329
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2017
• Initial Report FDA Received Date: 06/30/2017
• 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