MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,2.5 MICRO,22MM LGTH; SCREW, FIXATION, BONE

Model Number	COMPR FT SCRW,2.5 MICRO,22MM LGTH
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/13/2021
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2021, it was reported by a sales representative via e-mail that while using an ar-8725-22h, micro compression ft, the surgeon noticed after insertion of the screw that there was an artifact on the distal end of the screw that could be seen via x-ray.This was discovered during use in a index finger dip fusion on (b)(6) 2021.The screw was left in the patient.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation identified what appears to be a fractured piece of the reported screw in the patient's hand.However, without the return of the device, further investigation cannot be performed.The root cause of the reported failure mode is undetermined.

• Brand Name: COMPR FT SCRW,2.5 MICRO,22MM LGTH
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12393801
• Report Number: 1220246-2021-03597
• Device Sequence Number: 4381619
• Product Code: HWC
• UDI-Device Identifier: 00888867126893
• UDI-Public: 00888867126893
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): 09/30/2021

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,2.5 MICRO,22MM LGTH
• Device Catalogue Number: AR-8725-22H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1