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

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 10/12/2023

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 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 (b)(6) 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.

• Brand Name: DYNANITE 1.1 DBL TIP NITI G-WIRE 2 ZONE
• Type of Device: 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: 18195212
• MDR Text Key: 328888085
• Report Number: 1220246-2023-08885
• 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: 11/22/2023

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?: Yes
• 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: 15088412
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/04/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other