MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK WITH SUTURETAPE; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	FIBERTAK WITH SUTURETAPE
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/11/2022
Type of Reportable Event	Serious Injury
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) 2022, it was reported by a sales representative via phone that an ar-3602 fibertak suture anchor was found broken via x-ray, during a three week post operative visit.Patient underwent a subpec bicep tenodesis procedure on (b)(6) 2022, which was completed successfully and no issues were reported.However, on (b)(6) 2022, surgeon noticed the fibertak had broken and a revision surgery has been schedule for (b)(6) 2022.No further information has been given as of today.Additional information received on (b)(6) 2022: the 20mm fibertak inserter piece came out without incident, and in one piece.The anchor held the tenodesis as well.Additional information received (b)(6) 2022: revision procedure took place on 5/16/2022 at the same facility as the original procedure and performed by the same surgeon.Nothing was explanted during revision surgery as the fibertak anchor was still holding on to the tenodesis.Case was completed successfully without further issues.

• Brand Name: FIBERTAK WITH SUTURETAPE
• 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: 14674660
• Report Number: 1220246-2022-05060
• Device Sequence Number: 5084154
• Product Code: MBI
• UDI-Device Identifier: 00888867206946
• UDI-Public: 00888867206946
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K181769
• 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): 06/13/2022

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 Model Number: FIBERTAK WITH SUTURETAPE
• Device Catalogue Number: AR-3602
• Device Lot Number: 14917758
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 06/13/2022
• Date Device Manufactured: 01/24/2022
• 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