MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE® STAPLE DRILL BIT, CAL, 2.0

Model Number	DYNANITE® STAPLE DRILL BIT, CAL, 2.0
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 8/19/2021 it was reported by sales representative via sems that an ar-8717d-02 got stuck in the drill guide ar-8717g-02 side "15" during a case.This occurred again during another procedure, where ar-8717d-02 got stuck in the drill guide ar-8717g-02 side "13".No patient affected.
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.Complaint confirmed, one drill bit broke off and the distal fragment remained contained and stuck within the frill guide; while the other device has heavy abrasion marks on the od near the distal end.The od of both devices met specifications.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, 2.0
• 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: 19380589
• Report Number: 1220246-2024-03702
• Device Sequence Number: 12667446
• Product Code: HTW
• UDI-Device Identifier: 00888867326200
• UDI-Public: 00888867326200
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2024

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, 2.0
• Device Catalogue Number: AR-8717D-02
• Device Lot Number: 032006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2020
• 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