MAUDE Adverse Event Report: ARTHREX, INC. DX FIBERTAK SUTURE ANCHOR, #1 FW & NDLS; NON-DEGRADABLE FIXATN FASTENER

Model Number	DX FIBERTAK SUTURE ANCHOR, #1 FW & NDLS
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 02/14/2024, it was reported by an arthrex subsidiary employee via e-mail that an ar-8990 fibertak¿ dx suture anchors inserter shaft was crushed, resulting in poor insertion.This occurred during a procedure upon inserting it into the fibula, the inserter shaft was crushed, resulting in poor insertion.The bone was prepped using a f1.6mm drill inside the ar-8990ds.The surgeon created an additional bone hole with a f1.8mm k wire and inserted it again.He was able to insert it with little resistance, and to recover without any fixation problems.Additional information provided 2/20/24: the procedure performed was a atfl repair.Nothing broke off inside of the patient.No images or videos are available.
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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 complaint allegation is confirmed.Upon visual inspection, it was noted that the distal end of the shaft of the fibertak¿ dx suture anchor, #1 fw w/needles, ve5 had twisted.Functional testing was not performed due to the damage to the device.The method of bone preparation and the quality of the bone encountered were provided.The most likely cause for the reported failure can be attributed to improper bone preparation, misaligned insertion, and prying/leveraging the device during insertion.

• Brand Name: DX FIBERTAK SUTURE ANCHOR, #1 FW & NDLS
• 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: jared engle ; 8009337001
• MDR Report Key: 18817565
• Report Number: 1220246-2024-01244
• Device Sequence Number: 17228942
• Product Code: MBI
• UDI-Device Identifier: 00888867265004
• UDI-Public: 00888867265004
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172612
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024

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 Model Number: DX FIBERTAK SUTURE ANCHOR, #1 FW & NDLS
• Device Catalogue Number: AR-8990
• Device Lot Number: 14964189
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2022
• 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