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	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the drill became stuck inside the guide.There was no harm for patient, operator or third party reported.This was noticed before the surgery.There was no case involvement reported.No further information received.Update 15-jan-2025: further information was received, on 05-jan-2026, that the case occurred during a surgery.The surgery was finished successfully with a new anchor.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• 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: 24114343
• Report Number: 1220246-2026-00244
• Device Sequence Number: 21257017
• Product Code: MDM
• UDI-Device Identifier: 00888867023864
• UDI-Public: (01)00888867023864(11)250721(17)300630(10)15469864
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 05/14/2026

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: 2.4MM BIO-SUTURETAK DISPOSABLES KIT
• Device Catalogue Number: AR-1934-24DS
• Device Lot Number: 15469864
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2025
• 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