MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE® STAPLE DRILL BIT, CAL, 1.6

Model Number	DYNANITE® STAPLE DRILL BIT, CAL, 1.6
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 02/14/2022 it was reported by a sales representative via sems that an ar-8717d-01 drill bit cold welded to the ar-8717g guide while drilling holes for the staple.The ar-8717g-01 (lot 04511920) was the only guide in the set, so the surgeon had to completed the tunnel without using a guide.The surgeon was able to insert the staple and complete the procedure.Picture attached i had to use pliers to wiggle/pry the drill out after the case.Please note the small metal shavings.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Device not expected to return.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.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: DYNANITE® STAPLE DRILL BIT, CAL, 1.6
• 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: 19483391
• Report Number: 1220246-2024-05180
• Device Sequence Number: 20827333
• Product Code: HTW
• UDI-Device Identifier: 00888867326194
• UDI-Public: 00888867326194
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/07/2024

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: DYNANITE® STAPLE DRILL BIT, CAL, 1.6
• Device Catalogue Number: AR-8717D-01
• Device Lot Number: 031922
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2019
• 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