MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,3.5 MINI,18MM LGTH; SCREW, FIXATION, BONE

Model Number	COMPR FT SCRW,3.5 MINI,18MM LGTH
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Reaction (2414)
Date of Event	05/06/2019
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 part remains in the patient.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 a patient is experiencing a possible allergic reaction after having an ar-8730-18h, mini compression ft implanted.The rep stated they do not have any further details or information regarding the reaction at this time.A request has been made for the rep to follow-up with the surgeon and obtain additional information.Additional information received on 05/30/2019: the type of procedure that originally took place was a scarf osteotomy.The date of the original procedure is unknown.The surgeon confirmed to the arthrex sales representative that the surgical site is not infected.However, the patient does appear to be having a reaction.The surgeon stated there is a possibility that a removal will take place in the near future.

• Brand Name: COMPR FT SCRW,3.5 MINI,18MM LGTH
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8660167
• Report Number: 1220246-2019-01128
• Device Sequence Number: 2286693
• Product Code: HWC
• UDI-Device Identifier: 00888867126985
• UDI-Public: 00888867126985
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K182361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/31/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: COMPR FT SCRW,3.5 MINI,18MM LGTH
• Device Catalogue Number: AR-8730-18H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 05/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other