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
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11590649
• Report Number: 1220246-2021-02794
• Device Sequence Number: 19799954
• Product Code: HRS
• UDI-Device Identifier: 00888867303485
• UDI-Public: 00888867303485
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K201132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: COMPR FT SCRW,2.5 MICRO, 50MM
• Device Catalogue Number: AR-8725-50H
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1