MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE PIP - BENT 14MM - W/INSTR; PIN, FIXATION, SMOOTH

Model Number DYNANITE PIP - BENT 14MM - W/INSTR

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 06/16/2022

Event Type  malfunction  

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.The complaint is confirmed based on the customer provided photo, which displays the broken implant.The most likely cause for the reported failure can be attributed to a patient-specific event.

Event Description

On (b)(6) 2022, it was reported by a sales representative via email that an ar-4158ds-14b dynanite pip hammertoe implant has broken after nine weeks of post operation.The implant appears to be fused and the surgeon is not planning on removing it as of now.This was discovered during a post operative visit on (b)(6) 2022, via x-rays.Additional information has been received on 6/14/2022: the procedure took place on (b)(6) 2022 and it was completed successfully.

• Brand Name: DYNANITE PIP - BENT 14MM - W/INSTR
• 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: jared engle ; 8009337001
• MDR Report Key: 19190746
• MDR Text Key: 341717330
• Report Number: 1220246-2024-02439
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867310001
• UDI-Public: 00888867310001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/26/2024

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
• Device Operator: Health Professional
• Device Model Number: DYNANITE PIP - BENT 14MM - W/INSTR
• Device Catalogue Number: AR-4158DS-14B
• Device Lot Number: 10448930
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/16/2022
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1