MAUDE Adverse Event Report: ARTHREX, INC. 5.5MM BC CORKSCREW FT W/ SUTURETAPE; BIO SOFT TISSUE FIXATN FASTNR

Model Number	5.5MM BC CORKSCREW FT W/ SUTURETAPE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/09/2025, a sales representative reported via email that an ar-1927bct biocomposite corkscrew ft suture anchor broke halfway through implantation.The bone was pre-punched with a silver corkscrew punch at the tuberosity for a supraspinatus repair.All broken fragments were reportedly retrieved.The case was completed, although part of the anchor remained in the patient¿s bone.This was discovered during a rotator cuff repair procedure on (b)(6) 2025.Additional information was received on 10/13/2025: the nature of the breakage of the anchor was in half, with the top third of the implant remaining on the inserter.All broken pieces were retrieved from the patient.The case was completed with ar-1927bct biocomposite corkscrew ft suture anchor.The case was delayed five minutes, and it is unknown if additional anesthesia was administered.The bone quality of the patient was assessed as normal, and the ar-1927pb punch was used for bone preparation.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, 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.

• Brand Name: 5.5MM BC CORKSCREW FT W/ SUTURETAPE
• 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: 23303204
• Report Number: 1220246-2025-04618
• Device Sequence Number: 13243382
• Product Code: MAI
• UDI-Device Identifier: 00888867251267
• UDI-Public: (01)00888867251267(11)250623(17)270531(10)15454635
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K082810
• 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): 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: 5.5MM BC CORKSCREW FT W/ SUTURETAPE
• Device Catalogue Number: AR-1927BCT
• Device Lot Number: 15454635
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• 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: 06/23/2025
• 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