MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,4.0 STD,48MM LGTH; PLATE, FIXATION, BONE

Model Number	COMPR FT SCRW,4.0 STD,48MM LGTH
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a dex procedure, when the surgeon was entering the screw, it breaks without being forced.The surgeon was able to remove the device by using an instruments from another manufacturer.The case was completed by using a new device.
Additional Manufacturer Narrative
It was reported that the screw broke.Visual evaluation identified that the screw had fractured in half.However, without the return of the device, further investigation cannot be performed.The root cause of the reported failure mode is undetermined as the device was not returned.The reported event is confirmed based on the investigation of the returned picture.

• Brand Name: COMPR FT SCRW,4.0 STD,48MM LGTH
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11946541
• Report Number: 1220246-2021-03202
• Device Sequence Number: 4359305
• Product Code: HRS
• UDI-Device Identifier: 00888867127906
• UDI-Public: 00888867127906
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K201132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2021

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: COMPR FT SCRW,4.0 STD,48MM LGTH
• Device Catalogue Number: AR-8740-48H
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/20/2021
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1