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

Model Number	DYNANITE PIP - STR 14MM - W/INSTR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is currently still implanted in the patient.Additionally, without the return of the product, further investigation cannot be performed; however, the most likely cause for the reported failure can be attributed to a patient-specific event.
Event or Problem Description
It was reported during a surgery on (b)(6) 2020 ar-4158ds-14s was implanted.The product was implanted per standard surgical technique/procedure.The product was noted still intact during a follow-up visit on (b)(6) 2020.The implanted product was discovered broken during a follow-up visit on (b)(6) 2021.The surgeon plans to schedule a revision surgery to remove the broken implant.See source data attached.

• Brand Name: DYNANITE PIP - STR 14MM - W/INSTR
• Common Device Name: 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: 18255252
• Report Number: 1220246-2023-09098
• Device Sequence Number: 7059479
• Product Code: HTY
• UDI-Device Identifier: 00888867310018
• UDI-Public: 00888867310018
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K190287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/04/2023

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 Model Number: DYNANITE PIP - STR 14MM - W/INSTR
• Device Catalogue Number: AR-4158DS-14S
• Device Lot Number: 10381487
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown