MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE 1.1 DBL TIP NITI G-WIRE 2 ZONE; SMOOTH FIXATION PIN

Model Number	DYNANITE 1.1 DBL TIP NITI G-WIRE 2 ZONE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 10/25/2023, it was reported by a sales representative via sems-06066780 that an ar-4159-11d flexwire broke two weeks post-operation.On 6/22/2023, a patient underwent a second and third hammertoes procedure in which an ar-4158ds-12s dynanite pip was implanted along with the flexwire.Two weeks later, during a post-operation visit, it was confirmed that the flexwire at the second mtp joint was broken; the third wire was intact.Both wires were removed during the office visit.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint is confirmed by the customer's x-ray, which shows the dynanite 1.1 doble tip nitinol g-wire broken into two pieces.Based on the information provided and the evaluation of the customer¿s x-rays, a patient-specific event may be the most likely cause of the reported failure.The directions for use (dfu) dfu-0152-4 at revision 0.E.Warnings.6.Postoperatively and until healing is complete, fixation provided by this device should be considered as temporary and may not withstand weight bearing or other unsupported stress.The fixation provided by this device should be protected.The postoperative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the device.

• Brand Name: DYNANITE 1.1 DBL TIP NITI G-WIRE 2 ZONE
• Common Device Name: SMOOTH FIXATION PIN
• 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: emily shafer ; 8009337001
• MDR Report Key: 18184366
• Report Number: 1220246-2023-08846
• Device Sequence Number: 20735822
• Product Code: HTY
• UDI-Device Identifier: 00888867334892
• UDI-Public: 00888867334892
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K200068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: DYNANITE 1.1 DBL TIP NITI G-WIRE 2 ZONE
• Device Catalogue Number: AR-4159-11D
• Device Lot Number: 15015638
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown