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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2023
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 8/28/2023, it was reported by an arthrex subsidiary employee via sems-06016980 that an ar-1250lt step drill broke during a brostrom procedure on (b)(6) 2023.The bone tunnel was completed before the drill broke.The broken part was recovered, and there was no harm to the patient.It was possible to insert the anchor, and the surgery was completed successfully.The drill fragments were disposed of at the hospital.This occurred during use with no patient harm.Additional information has been requested.On (b)(6) 2023, the arthrex subsidiary employee provided the following information via email: there was no case delay reported.This event was not an adverse reportable event and did not meet the reportability requirements of article 8 of rdc 67/2009.
Additional Manufacturer Narrative
Complaint allegation was not confirmed.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(s) for the reported failure can be a user error due to improper bone preparation, misaligned insertion, and/or prying/levering the device during insertion.

• 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: emily shafer ; 8009337001
• MDR Report Key: 17816964
• Report Number: 1220246-2023-07974
• Device Sequence Number: 16764359
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2024

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 DRL,2.4MM/3.0MM TISSTAK/BIO-S-TAK
• Device Catalogue Number: AR-1250LT
• Device Lot Number: 1192995
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2023
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2010
• Is the Device Labeled for Single Use? (Y/N): No
• 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