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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
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
It was reported that during a shoulder instability repair surgery an issue with the reported device has occurred.The surgeon has drilled the hole and when he tried to remove the drill, it that got stuck.The tip of the drill fused with part of the sleeve, while the lower part, where the drill is attached, broke off.The piece was recovered and did not remain inside the patient.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new different device.It was not necessary to switch the surgical technique or do a second surgery.
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 for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces and/or prying/leveraging the device during use.

• 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: 21942701
• Report Number: 1220246-2025-01831
• Device Sequence Number: 20969342
• Product Code: MDM
• UDI-Device Identifier: 00888867023864
• UDI-Public: (01)00888867023864(11)210526(17)260430(10)13394942
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 10/31/2025

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 Expiration Date: 04/30/2026
• Device Model Number: 2.4MM BIO-SUTURETAK DISPOSABLES KIT
• Device Catalogue Number: AR-1934-24DS
• Device Lot Number: 13394942
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown