MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK DR LBRLTAPE WH/BL & TT WH/BLK; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	FIBERTAK DR LBRLTAPE WH/BL & TT WH/BLK
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/07/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On (b)(6) 2021 it was reported by a sales representative via email that an ar-3651tt, fibertak dr lbrltape, was being used in an rcr procedure.During insertion, the fork tip of the anchor broke off within the patient's joint and was unable to be retrieved.The case was completed with a second anchor with the same pn without further incident.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation confirms that one of the fork tips, at the distal end has broken off.Broken piece and suture were not returned for evaluation.Device functioning was not performed due to the broken condition of the device.The cause of this event is undetermined; however, a most likely cause of this event is the application of prying/leveraging forces to the device during use.

• Brand Name: FIBERTAK DR LBRLTAPE WH/BL & TT WH/BLK
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, 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: 13087737
• Report Number: 1220246-2021-04181
• Device Sequence Number: 5387074
• Product Code: MBI
• UDI-Device Identifier: 00888867225053
• UDI-Public: 00888867225053
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K200341
• 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,Followup
• Report Date (Section B): 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: FIBERTAK DR LBRLTAPE WH/BL & TT WH/BLK
• Device Catalogue Number: AR-3651TT
• Device Lot Number: 14357495
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 12/27/2021
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown