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

Model Number	DYNANITE NITI STAPLE W/INSTRS 9WX10L
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an akin technology surgery with dynanite staples the drill bit welded itself to the drill guide during drilling.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Upon visual inspection, it was noted that the 1.6mm drill bit was returned stuck inside one of the holes of the drill guide 9mm of the dynanite¿ nitinol staple implant system, 9w x 10l.Functional testing revealed that the drill bit could not be removed from the drill guide.The most likely causes of the reported failure are misaligned insertion, and prying/leveraging the device during insertion.

• 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: jared engle ; 8009337001
• MDR Report Key: 19966898
• Report Number: 1220246-2024-07150
• Device Sequence Number: 21046910
• Product Code: JDR
• UDI-Device Identifier: 00888867288058
• UDI-Public: 00888867288058
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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,Followup
• Report Date (Section B): 10/14/2024

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 NITI STAPLE W/INSTRS 9WX10L
• Device Catalogue Number: AR-8717DS-0910
• Device Lot Number: 3339136918
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2024
• 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