MAUDE Adverse Event Report: ARTHREX, INC. DBL LOADED 4.75MM BC SWVLK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	DBL LOADED 4.75MM BC SWVLK
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 8/19/2025, it was reported by a sales representative via email that an ar-2324bct-2 biocomposite swivelock metal shaft bent upon impacting the eyelet.This was discovered during an acl repair procedure on (b)(6) 2025.Additional information was received on 08/27/2025: during the procedure, the eyelet of the ar-2324bct-2 biocomposite swivelock broke off inside the patient.All fragments were successfully retrieved.The case was completed using another ar-2324bct-2 biocomposite swivelock and the same technique.The procedure experienced a brief two-minute delay, and no additional anesthesia was administered.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-2324bct-2 batch 15434588 was received for evaluation.Visual evaluation revealed that the eyelet was bent, as well as the inner shaft tube.Functional testing was not performed due to the device damage.This includes improper bone preparation, misaligned insertion, and/or prying or levering the device during insertion.These factors may have contributed to the malfunction or compromised the integrity of the implant during the procedure.

• Brand Name: DBL LOADED 4.75MM BC SWVLK
• 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: 23003458
• Report Number: 1220246-2025-03761
• Device Sequence Number: 15661743
• Product Code: MAI
• UDI-Device Identifier: 00888867251236
• UDI-Public: (01)00888867251236(11)250512(17)270430(10)15434588
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• 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): 12/05/2025

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: DBL LOADED 4.75MM BC SWVLK
• Device Catalogue Number: AR-2324BCT-2
• Device Lot Number: 15434588
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 08/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown