MAUDE Adverse Event Report: ARTHREX, INC. CORKSCREW FT, BC, SUTURETAPE, 4.75MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	CORKSCREW FT, BC, SUTURETAPE, 4.75MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 13th oct 2025, it was reported by an arthrex's employee via an email that for 2 units of ar-1927bct-475, suture anchor, biocomposite¿ corkscrew® ft, double loaded with two 1.3 m m suturetape¿, 4.75 mm, both the implants broke intra operation.This was detected during a rotator cuff repair on (b)(6) 2025.The procedure was completed successfully by using a new anchor.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed.Photographic evidence provided from the field of an ar-1927bct-475, with batch number 15304827, revealed that the anchor was damaged.Therefore, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to misaligned insertion; prying/leveraging the device during insertion.Per dfu-0087-eo revision 4: 6.Bioabsorbable only: attempting implantation into hard, dense bone and/or drilling/punching smaller diameter holes than recommended may cause failure (breakage) of the implant during insertion.

• Brand Name: CORKSCREW FT, BC, SUTURETAPE, 4.75MM
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 23302777
• Report Number: 1220246-2025-04624
• Device Sequence Number: 15934302
• Product Code: MAI
• UDI-Device Identifier: 00888867237858
• UDI-Public: (01)00888867237858(11)240820(17)280731(10)15304827
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K173788
• 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): 11/07/2025

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: CORKSCREW FT, BC, SUTURETAPE, 4.75MM
• Device Catalogue Number: AR-1927BCT-475
• Device Lot Number: 15304827
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2024
• 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