MAUDE Adverse Event Report: ARTHREX, INC. QCKFIX SCRW,TI,CANN.,PT,2.4X 18MM; SCREW, FIXATION, BONE

Model Number	QCKFIX SCRW,TI,CANN.,PT,2.4X 18MM
Health Effect - Clinical Codes	Rash (2033); Reaction (2414)
Date of Event	02/04/2020
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.
Event or Problem Description
It was reported a patient had left bunionectomy (b)(6) 2019 and developed an allergic reaction.He has a rash on the left foot which has spread to the lower left leg.This was reported by an allergy center.They also reported there was a revision to remove the screws and the reaction has been cleared up the caller stated the patient is fine to date.

• Brand Name: QCKFIX SCRW,TI,CANN.,PT,2.4X 18MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9750588
• Report Number: 1220246-2020-01693
• Device Sequence Number: 11520491
• Product Code: HWC
• UDI-Device Identifier: 00888867045163
• UDI-Public: 00888867045163
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/25/2020

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: QCKFIX SCRW,TI,CANN.,PT,2.4X 18MM
• Device Catalogue Number: AR-8724-18PT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 02/25/2020
• 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