MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE® STAPLE DRILL GUIDE, 13 / 15 MM; MANUAL INSTR, GENERAL SURGICAL

Model Number	DYNANITE® STAPLE DRILL GUIDE, 13 / 15 MM
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
Type of Reportable Event	Malfunction
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, the id of one of the guides is severely damaged.The undamaged ids were found to meet specifications.A likely cause of the event is prying/leveraging the mating drill bit during use.
Event or Problem Description
It was reported that when drilling from the guide sleeve part, it did not proceed smoothly.The contact area at the base of the drill had a scorched mark.A new guide and drill was opened and used to complete the case with no adverse effect to the patient.

• Brand Name: DYNANITE® STAPLE DRILL GUIDE, 13 / 15 MM
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 19185872
• Report Number: 1220246-2024-02416
• Device Sequence Number: 7403714
• Product Code: MDM
• UDI-Device Identifier: 00888867326101
• UDI-Public: 00888867326101
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 04/25/2024

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: DYNANITE® STAPLE DRILL GUIDE, 13 / 15 MM
• Device Catalogue Number: AR-8717G-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown