MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX CHONDRAL DART, 18MM (5-BOX); FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	ARTHREX CHONDRAL DART, 18MM (5-BOX)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via email that an ar-4005b-18 chondral dart would not seat.Surgeon started with the multi-use guide and inserted all 4 drill pins.Then the first drill pin was pulled and inserted guide, implant, and started impacting gently.Implant push rod would not seat fully.Surgeon pulled implant inserter out to see chondral dart was compacted and jammed in inserter.A single shot guide was opened to get another inserter.Surgeon proceeded to pull additional drill pins to try new holes.Two of these drill pins came out of the guide with broken tips.Implants continued not to seat all the way and stay mid-substance inside chondral flap.Eventually, surgeon bailed out to just a single shot guide and was very careful with holding the guide still, cycling the drill 3-4 times, and gently tapping the dart in place.This one looked perfect, but when the guide was lifted, the flap lifted off the bony surface.Upon inspection, the back side of the chondral defect had exposed chondral darts and both drill tips.Surgeon was able to retrieve all darts and drill tips with an arthroscopic grasper.Surgeon speculated that the drill bit was fully puncturing the defect, but potentially skiving on subchondral bone.It was always the last few millimeters on the push rod that seemed to be the issues.And that's why the implants were full thickness into the defect, but none of them made it into subchondral bone.Biocompression screws were not available so surgeon opted to resect the defect and schedule the patient for a future oats procedure.This was discovered during a knee arthroscopy with repair of osteochondral defect on (b)(6) 2022.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

• Brand Name: ARTHREX CHONDRAL DART, 18MM (5-BOX)
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 14914561
• Report Number: 1220246-2022-05157
• Device Sequence Number: 1881726
• Product Code: MAI
• UDI-Device Identifier: 00888867031166
• UDI-Public: 00888867031166
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K082999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/05/2022

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: 08/28/2024
• Device Model Number: ARTHREX CHONDRAL DART, 18MM (5-BOX)
• Device Catalogue Number: AR-4005B-18
• Device Lot Number: 7008252
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 07/05/2022
• Date Device Manufactured: 09/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown