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

Model Number	COMPR FT SCRW,2.5 MICRO, 50MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/08/2023
Type of Reportable Event	Serious Injury
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 10/04/2023, it was reported by a patient's relative, via phone, that on (b)(6) 2023 the patient underwent a metacarpal fracture screw fixation when a screw snapped in half during insertion.The screw had to be burred down as it could not be removed.Burring the device down resulted in debris being produced.It took about an hour to irrigate the fragments from the patient.The patient's hand had to be cut open to continue with the procedure resulting in an extended recovery time.There was no additional information provided and additional information has been requested.Additional information was provided on 10/05/2023.It was reported that an ar-8725-50h micro compression ft broke during the procedure.Additional information was provided via phone on 10/31/2023: the wife of the patient advised that the facility will not provide any additional information regarding the case.She has asked for the surgeon to provide all the products that were used and they advised this information is not available.Per the wife, the surgeon stated the issue was with the implant and that a revision will not be performed, as the screw cannot be removed because the patient could experience loss of bone.Post-operative x-rays were taken and will be provided via email.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces and/or prying/leveraging the device during use.

• Brand Name: COMPR FT SCRW,2.5 MICRO, 50MM
• Common Device Name: 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: emily shafer ; 8009337001
• MDR Report Key: 18067222
• Report Number: 1220246-2023-08546
• Device Sequence Number: 7615423
• Product Code: HWC
• UDI-Device Identifier: 00888867303485
• UDI-Public: 00888867303485
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K201132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown