MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE NITI STAPLE W/INSTRS 15WX15L; STAPLE, FIXATION, BONE

Model Number	DYNANITE NITI STAPLE W/INSTRS 15WX15L
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/27/2021, it was reported by an arthrex employee via email that an ar-8719ds-1515 staple implant system cannot be fitted.The staple and the device can not be fitted.A new device was used and the case was completed.There was no patient effect reported.Additional information requested.Additional information provided on 10/28/2021: the hook part of the device did not fit the staple and could not be attached.Procedure being performed was hallux valgus distal osteotomy.
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 unpackaged c14771-08 staple delivery device from an ar-8719ds-1515 was received for investigation.Visual inspection identified that the knob assembly had be bent out of position.Functional testing with a sample staple revealed that the staple was able to be secured onto the device but was slightly out of position.The most likely cause for the reported failure can be attributed to user error of the device due to user-applied mechanical forces to the knobs.

• Brand Name: DYNANITE NITI STAPLE W/INSTRS 15WX15L
• 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: 19392458
• Report Number: 1220246-2024-03863
• Device Sequence Number: 18083032
• Product Code: JDR
• UDI-Device Identifier: 00888867288126
• UDI-Public: 00888867288126
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/24/2024

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 15WX15L
• Device Catalogue Number: AR-8719DS-1515
• Device Lot Number: 307107610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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