MAUDE Adverse Event Report: ARTHREX, INC. QCKFIX SCRW,TI,CANC.,PT,3.0X 18MM; SCREW, FIXATION, BONE

Model Number	AR-8730-18PT
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	04/26/2021
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
It was reported by the patient that 5 weeks ago she had foot surgery that involves 2 of arthrex cannulated screws.The patient believes there is a possibility that she may be experiencing a metal sensitivity.The device is a titanium alloy.

• Brand Name: QCKFIX SCRW,TI,CANC.,PT,3.0X 18MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12075283
• Report Number: 1220246-2021-03314
• Device Sequence Number: 3848772
• Product Code: HWC
• UDI-Device Identifier: 00888867045781
• UDI-Public: 00888867045781
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/28/2021

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: AR-8730-18PT
• Device Catalogue Number: QCKFIX SCRW,TI,CANC.,PT,3.0X 1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 06/28/2021
• 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