MAUDE Adverse Event Report: ARTHREX, INC. STEP DRILL, 2.4MM, BIO-SUTURETAK; DRILL BIT

Model Number	STEP DRILL, 2.4MM, BIO-SUTURETAK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 12/4/2023, it was reported by an arthrex subsidiary employee via sems-06421551 that an ar-1934d-24 drill for a 2.4 mm suturetak drill bit broke inside the bone.The technique was carried out correctly, but the patient's bone was hard, and when the surgeon pushed too hard, it broke.The tip remained implanted in the patient.The case was completed successfully with no information provided.This was discovered during an elbow triceps procedure on 11/27/2023.
Additional Manufacturer Narrative
Additional info: b5, g3, h6.
Event or Problem Description
Additional information was received on 12/21/2023: the case was completed by finishing the hole.The surgeon used kirchner wire number 2 to pass the wire through and attach it to the anchor.The surgery took one hour and fifty minutes (starting at 6:20 pm and ending at 8:10 pm).There was no report of adverse effects on the patient.X-ray is attached.
Additional Manufacturer Narrative
The complaint is confirmed based on the customer provided photo, which displays that the distal end of the drill had broken.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: STEP DRILL, 2.4MM, BIO-SUTURETAK
• 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: emily shafer ; 8009337001
• MDR Report Key: 18384993
• Report Number: 1220246-2023-09592
• Device Sequence Number: 16813078
• Product Code: HTW
• UDI-Device Identifier: 00888867024045
• UDI-Public: 00888867024045
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2024

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 DRILL, 2.4MM, BIO-SUTURETAK
• Device Catalogue Number: AR-1934D-24
• Device Lot Number: 10040433
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 12/21/2023; 05/14/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 04/26/2024; 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2016
• 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