MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE NITI STAPLE W/INSTRS 9WX10L; STAPLE, FIXATION, BONE

Model Number	DYNANITE NITI STAPLE W/INSTRS 9WX10L
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint confirmed, the 1.6 mm drill bit was found to be stuck in the drill guide metallic section, which also broke off from the handle.Heat damage was observed on the handle.Available features were measured and found to meet specifications.A likely cause of the event is prying/leveraging the drill bit during use, resulting in excessive friction and heat.
Event or Problem Description
On (b)(6) 2021, it was reported by a arthrex employee via e-mail that a ar-8717ds-0910 dynanite is damaged.This occurred during an unknown procedure when used normally, the dollar part was damaged.The case was completed using a new product.No additional information provided.Additional information requested.Additional information provided on 12/23/2021: the procedure being performed was a akin osteotomy.The drill was damaged in the guide, all debris produced was removed.A new drill of an unknown part number was used to complete the case.

• Brand Name: DYNANITE NITI STAPLE W/INSTRS 9WX10L
• Common Device Name: STAPLE, FIXATION, BONE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 13620520
• Report Number: 1220246-2022-04517
• Device Sequence Number: 13977219
• Product Code: JDR
• UDI-Device Identifier: 00888867288058
• UDI-Public: 00888867288058
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203180
• 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): 02/28/2022

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 Expiration Date: 04/30/2025
• Device Model Number: DYNANITE NITI STAPLE W/INSTRS 9WX10L
• Device Catalogue Number: AR-8717DS-0910
• Device Lot Number: 0125103498
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown