MAUDE Adverse Event Report: ARTHREX, INC. SP FBRTAK RC FBRTPE BLU & STTPE WH/BLK; NON-DEGRADABLE FIXATN FASTENER

Model Number	SP FBRTAK RC FBRTPE BLU & STTPE WH/BLK
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/08/2024
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.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via phone that an ar-3652tsp fibertak® rc suture anchor, and an ar-3652ttsp fibertak® rc suture anchor bent, and an ar-3650ds disposables kit was wasted.This occurred during a rotator cuff repair on (b)(6) 2024 the first anchor, ar-3652tsp was a self-punch and when attempting to insert it was bent.Then ar-3652ttsp ar-3652ttsp punched a hole and tried to insert which resulted in a bend.Then drill bit was used to attempt to make a bigger hole yet the anchor would still not go in.An ar-3650ds kit was used in this case and wasted.The patient had a hard bone.The case was completed using an ar-2324bcctt suture anchor.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Upon visual evaluation, it was noted that the distal tip of the inserter shaft of the fibertak® rc suture anchor, (blue) had bent.The fibertak rc, ft (blue), st (white/black) with the implant assembled that was noted to be frayed on one side of the sheath.The method of bone preparation and the quality of the hard bone encountered were provided.The most likely cause for the reported failure can be attributed to improper bone preparation, misaligned insertion; prying/leveraging the device during insertion.Per dfu-0054-eo rev 5 e warnings - 9.Suturetak and fibertak suture anchors only: drilling in very hard bone may require cycling the drill while maintaining consistent alignment of the drill guide.Increased size, hard bone drills are also available for use.Precautions - 9.Self-punching suture anchors only: ensure that the angle of anchor insertion is perpendicular to the bone.Functional testing was not performed due to the damage to the device.

• Brand Name: SP FBRTAK RC FBRTPE BLU & STTPE WH/BLK
• 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: 18793960
• Report Number: 1220246-2024-01159
• Device Sequence Number: 20615843
• Product Code: MBI
• UDI-Device Identifier: 10888867362922
• UDI-Public: 10888867362922
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K203268
• 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): 08/30/2024

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: SP FBRTAK RC FBRTPE BLU & STTPE WH/BLK
• Device Catalogue Number: AR-3652TSP
• Device Lot Number: 15173252
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 08/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2023
• 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