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

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

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 01/25/2021

Event Type  malfunction  

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 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
• 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: 18255252
• MDR Text Key: 329574404
• Report Number: 1220246-2023-09098
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867310018
• UDI-Public: 00888867310018
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/11/2021
• Initial Date FDA Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: No
• 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