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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
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
It was reported that during a rotator cuff repair surgery the corckscrew broke.All broken parts were retrieved from the patient.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-1927bct-1 suture anchor, biocomposite¿ corkscrew® ft, vented 5.5 mm, batch 15489699 was received for evaluation.During the visual evaluation, it was observed that the anchor was broken and missing half of its body.The anchor had been passed through the suture.No additional damage was identified on the suture, the inserter tip, or the handle.A functional test was not performed due to device damage.The most likely cause of the reported failure is user error, including improper bone preparation, excessive side-loading forces, and leveraging the device during insertion/use.Refer to the investigation pictures.The complaint allegation about the corkscrew broke was confirmed.

• 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: 24305556
• Report Number: 1220246-2026-00501
• Device Sequence Number: 18561818
• Product Code: MAI
• UDI-Device Identifier: 00888867264595
• UDI-Public: (01)00888867264595(11)250827(17)270731(10)15489699
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K082810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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-1
• Device Lot Number: 15489699
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2025
• 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