MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,2.5 MICRO,20MM LGTH; BONE FIXATION SCREW/PLATE

Model Number	COMPR FT SCRW,2.5 MICRO,20MM LGTH
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/27/2024
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 03/27/2024, it was reported by a sales representative via email that an ar-8725-20h micro compression ft tip broke off in the patient.The broken fragment was not removed.This was discovered during a distal interphalangeal arthrodesis procedure on 3/27/2024.Additional information received on 3/29/2024: the case was completed using another ar-8725-20h micro compression ft.All the broken fragments remain in the patient's middle phalanx.The case was delayed an additional thirty minutes and additional anesthesia was administered.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Upon visual inspection, it was noted that one of the tips of the micro compression ft¿, titanium, 2.5 mm x 20 mm had broken off.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error due to misaligned insertion; and prying/leveraging the device during insertion.

• Brand Name: COMPR FT SCRW,2.5 MICRO,20MM LGTH
• 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: jared engle ; 8009337001
• MDR Report Key: 19155046
• Report Number: 1220246-2024-02222
• Device Sequence Number: 7548514
• Product Code: HWC
• UDI-Device Identifier: 00888867126886
• UDI-Public: 00888867126886
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 08/19/2024

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,2.5 MICRO,20MM LGTH
• Device Catalogue Number: AR-8725-20H
• Device Lot Number: 047412330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 08/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2023
• 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
• Patient Sex: Unknown