MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,3.5 MINI, 36MM; BONE FIXATION SCREW/PLATE

Model Number COMPR FT SCRW,3.5 MINI, 36MM

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/13/2023

Event Type  Injury  

Event Description

It was reported that after an initial arthrodesis surgery for hallux rigidus on 22nd (b)(6)2022 the patient developed an granuloma formation.A surgical exploration was performed and a fragment of the screw was identified.An additional surgery was performed on (b)(6) 2023 to perform a fresection of the ganuloma.

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.

• Brand Name: COMPR FT SCRW,3.5 MINI, 36MM
• Type of Device: BONE FIXATION SCREW/PLATE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16914538
• MDR Text Key: 315037612
• Report Number: 1220246-2023-06724
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888867303966
• UDI-Public: 00888867303966
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K201132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/11/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: COMPR FT SCRW,3.5 MINI, 36MM
• Device Catalogue Number: AR-8730-36HS
• Device Lot Number: 14695453
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/18/2023
• Initial Date FDA Received: 05/11/2023
• 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