MAUDE Adverse Event Report: Arthrex, Inc. BIO-COMP SWIVELOCK C, CLD 5.5x19.1MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMP SWIVELOCK C, CLD 5.5x19.1MM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 10th september 2026, it was reported by an arthrex's employee via an email that for 1 unit of ar-2323bcc, suture anchor, biocomposite swivelock® c, 5.5 mm x 19.1 mm, closed eyelet, its anchor pulled out during insertion.This was detected during a rotator cuff repair surgery on (b)(6)2026.The procedure was completed successfully by using another new ar-2323bcc.There were no patient harm and no secondary procedure needed.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: BIO-COMP SWIVELOCK C, CLD 5.5x19.1MM
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50898489
• Report Number: 1220246-2026-04904
• Device Sequence Number: 14952613
• Product Code: MAI
• UDI-Device Identifier: 00888867026728
• UDI-Public: (01)00888867026728(11)250217(17)290131(10)15390246
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K203495
• 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
• Report Date (Section B): 09/25/2026

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: BIO-COMP SWIVELOCK C, CLD 5.5x19.1MM
• Device Catalogue Number: AR-2323BCC
• Device Lot Number: 15390246
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2025
• 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