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

Model Number	FIBERTAK WITH SUTURETAPE
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The most likely cause for the reported failure can be attributed to user error due to misaligned insertion and/or improper bone preparation; however, due to the device not being returned, we are unable to confirm the reported event.
Event or Problem Description
On 11/10/2022, it was reported by a sales representative via sems that (2) ar-3602 fibertak suture anchor pulled out and frayed the sutures.This was discovered during a shoulder arthroplasty procedure on (b)(6) 2022.Both anchors were removed completely and new ar-3602 fibertak suture anchor were used to complete the case.

• Brand Name: FIBERTAK WITH SUTURETAPE
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: emily shafer ; 8009337001
• MDR Report Key: 18453815
• Report Number: 1220246-2024-00148
• Device Sequence Number: 15368740
• Product Code: MBI
• UDI-Device Identifier: 00888867206946
• UDI-Public: 00888867206946
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 01/05/2024

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: 06/30/2025
• Device Model Number: FIBERTAK WITH SUTURETAPE
• Device Catalogue Number: AR-3602
• Device Lot Number: 11239017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown