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

Model Number	DYNANITE PIP - BENT 14MM - W/INSTR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/16/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• 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: jared engle ; 8009337001
• MDR Report Key: 19190746
• Report Number: 1220246-2024-02439
• Device Sequence Number: 7694301
• Product Code: HTY
• UDI-Device Identifier: 00888867310001
• UDI-Public: 00888867310001
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K190287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown