MAUDE Adverse Event Report: ARTHREX, INC. STEP DRL,2.4MM/3.0MM TISSTAK/BIO-S-TAK; DRILL BIT

Model Number	STEP DRL,2.4MM/3.0MM TISSTAK/BIO-S-TAK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
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 06/20/2024 it was reported by an arthrex subsidiary employee via (b)(4) that an ar-1250lt step drill for 3.0mm bio-suturetaks tip broke off.This occurred during a case where the surgeon went to perform a transosseous tunnel in the patella with the suturetak drill, and because it is a hard bone, the tip of the drill broke off.However, it was possible to remove the fragment from the patient.No residue was left.
Event or Problem Description
On 06/28/2024 additional information was provided by the arthrex subsidiary employee via email who stated that the procedure being performed was a patellofemoral.All fragments were removed from the patient.The hospitals 2.0 guide wire was used to complete the procedure.
Additional Manufacturer Narrative
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 prying/leveraging the device during use.

• Brand Name: STEP DRL,2.4MM/3.0MM TISSTAK/BIO-S-TAK
• Common Device Name: DRILL BIT
• 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: 19721053
• Report Number: 1220246-2024-06701
• Device Sequence Number: 18175232
• Product Code: HWE
• UDI-Device Identifier: 00888867006287
• UDI-Public: 00888867006287
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/13/2025

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: STEP DRL,2.4MM/3.0MM TISSTAK/BIO-S-TAK
• Device Catalogue Number: AR-1250LT
• Device Lot Number: 1192994
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 06/28/2024; 06/06/2025
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 12/18/2024; 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/25/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown