MAUDE Adverse Event Report: ARTHREX, INC. 2.4MM BIO-SUTURETAK DISPOSABLES KIT; MANUAL INSTR, GENERAL SURGICAL

Model Number	2.4MM BIO-SUTURETAK DISPOSABLES KIT
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 06/05/2025, it was reported by a sales representative via (b)(4) that an ar-1934-24ds bio-suturetak disposable kit guides came out but the obturators were stuck inside of them and the drills did not pass through the guides.This was discovered during the case with no patient harm.
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 of the reported failure appears to be user-related, potentially due to misaligned insertion of the obturators into the guides or the application of excessive force through prying or leveraging, which may have compromised proper device function and prevented the drills from passing through as intended.

• Brand Name: 2.4MM BIO-SUTURETAK DISPOSABLES KIT
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 22349482
• Report Number: 1220246-2025-02691
• Device Sequence Number: 15581610
• Product Code: MDM
• UDI-Device Identifier: 00888867023864
• UDI-Public: (01)00888867023864(11)211105(17)261031(10)14475980
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 10/14/2025

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: 2.4MM BIO-SUTURETAK DISPOSABLES KIT
• Device Catalogue Number: AR-1934-24DS
• Device Lot Number: 14475980
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown