MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP SWVLK 3.5X 15.8MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMP SWVLK 3.5X 15.8MM
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
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 25th nov 2025, it was reported by an arthrex's employee via an email that for 1 unit of ar-2325bcc, suture anchor, biocomposite¿ swivelock®, 3.5 x 15.8 mm, vented, its anchor could not be inserted.It was found that the eyelet was detached.This was detected during a disital triceps repair on (b)(6) 2025.The procedure was completed successfully by using the complaint ar-2325bcc.There was no patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on photographic evidence of an ar-2325bcc from batch 15454877 showing a detached eyelet.Based on the information provided, which may include the returned device (if available), photographs, videos, event description, and any additional field input, arthrex has determined the most likely cause of the reported condition.The most likely cause is attributed to user-related factors, such as off-axis loading, improper bone preparation, and prying or leveraging the device with excessive force.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on review of photographic evidence of an ar-2325bcc swivelock® batch 15454877, which reveals a swivelock with the eyelet not present on the tip of the shaft.The eyelet is not visible in the photograph provided.The swivelock appears to be advanced, consistent with the usage of the device, which could additionally contribute to eyelet detachment.Based on the information available for review, which may include photographs, event description, and additional field input (a returned device was not required to confirm the condition), arthrex determined the most likely cause of the reported condition.The condition is most likely attributable to user-related factors, including one or more of the following: off-axis loading during anchor insertion.Improper bone preparation.Prying or levering of the device with excessive force.These factors are addressed in dfu-0087-eo, revision 6, section g.Precautions, which states: use the recommended drill bit or punch to create the bone socket.During anchor insertion, ensure that the angle of anchor insertion is coaxial with the previously prepared bone socket.Insert the driver into the bone socket until the anchor body makes contact with the bone.Preview and adjust suture tension, if necessary.Tension will not increase during the final advancement of the anchor body.Ensure that the anchor body is in full contact with the bone before advancing the anchor body into the prepared bone socket.

• Brand Name: BIO-COMP SWVLK 3.5X 15.8MM
• 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: 23780808
• Report Number: 1220246-2025-05598
• Device Sequence Number: 10079814
• Product Code: MAI
• UDI-Device Identifier: 00888867026957
• UDI-Public: (01)00888867026957(11)250623(17)270531(10)15454877
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K101823
• 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,Followup
• Report Date (Section B): 04/14/2026

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 SWVLK 3.5X 15.8MM
• Device Catalogue Number: AR-2325BCC
• Device Lot Number: 15454877
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 03/18/2026; 04/13/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 03/19/2026; 04/14/2026
• 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