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

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 10/27/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 304345991
• Report Number: 1220246-2022-05822
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867334892
• UDI-Public: 00888867334892
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 11/11/2022
• Initial Date FDA Received: 11/28/2022
• Date Device Manufactured: 10/05/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other