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

Model Number	DYNANITE 1.1 DBL TIP NITI G-WIRE 2 ZONE
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/27/2022
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
On 11/10/2022, it was reported by a sales representative via email that ar-4159-11d dynanite flexwire was found broken during a post operation office visit on (b)(6) 2022.The original procedure took place on (b)(6) 2022.Additional information received on 11/11/2022: surgeon removed the flexwire, revision surgery is date unknown at this time.Original procedure was performed due to a hammertoe correction and performed by the same surgeon, as well as the same facility.Additional information received on 11/14/2022: during the post-operation office visit on (b)(6) 2022, surgeon found that the flexwire was broken, and it was explanted immediately in the office.

• Brand Name: DYNANITE 1.1 DBL TIP NITI G-WIRE 2 ZONE
• Common Device Name: PIN, FIXATION, SMOOTH
• 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: 15868861
• Report Number: 1220246-2022-05822
• Device Sequence Number: 20505542
• Product Code: HTY
• UDI-Device Identifier: 00888867334892
• UDI-Public: 00888867334892
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K200068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/28/2022

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 Expiration Date: 09/30/2025
• Device Model Number: DYNANITE 1.1 DBL TIP NITI G-WIRE 2 ZONE
• Device Catalogue Number: AR-4159-11D
• Device Lot Number: 11837037
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 11/28/2022
• Date Device Manufactured: 10/05/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown