MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,2.5 MICRO, 50MM; PLATE, FIXATION, BONE

Model Number COMPR FT SCRW,2.5 MICRO, 50MM

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 03/04/2021

Event Type  malfunction  

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.

Event Description

It was reported that during a finger fracture repair procedure, as the surgeon was inserting the ar-8725-50h, the screw broke inside the bone.The surgeon was able to remove the broken screw by over drilling the insertion sight.The procedure was adjusted with prolonged anesthesia for 1/2 hour.The case was completed using competitors devices.

Manufacturer Narrative

Complaint confirmed.Two unpackaged ar-8725-50h fragments were received for investigation.No batch identifiers were available.It was determined that one fragment was approximately 31.90 mm, and the other measured in at approximately 17.98 mm.Material analysis testing concluded that both fragments met design specifications in terms of material grade.The observed condition is most likely the result of off-axis insertion and/or user applied mechanical forces to the device during use, such as through prying/leveraging.

• Brand Name: COMPR FT SCRW,2.5 MICRO, 50MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11590649
• MDR Text Key: 244191757
• Report Number: 1220246-2021-02794
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888867303485
• UDI-Public: 00888867303485
• Combination Product (y/n): N
• PMA/PMN Number: K201132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: COMPR FT SCRW,2.5 MICRO, 50MM
• Device Catalogue Number: AR-8725-50H
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1