MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,4.0 STD,30MM LGTH; PLATE, FIXATION, BONE

Model Number	COMPR FT SCRW,4.0 STD,30MM LGTH
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling/ Edema (4577)
Date of Event	07/12/2021
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 after 12 weeks post op from bunion surgery on (b)(6) 2021 the patient is experiencing swelling.Three screws were implanted and the patient feels she could be having an allergic reaction.The patient was in a hard cast for the first 30 days then to a walking boot at the 4th week.During the time right after the cast removal her foot became quite swollen and she experienced more than a moderate amount of pain.The patient elevated and iced the foot which relieved the pain to a tolerable amount but the swelling never went away.The patient is concerned she has a sensitivity to metal which could be causing this issue.

• Brand Name: COMPR FT SCRW,4.0 STD,30MM LGTH
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12267155
• Report Number: 1220246-2021-03454
• Device Sequence Number: 3531667
• Product Code: HRS
• UDI-Device Identifier: 00888867127685
• UDI-Public: 00888867127685
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 08/03/2021

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: COMPR FT SCRW,4.0 STD,30MM LGTH
• Device Catalogue Number: AR-8740-30H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 08/03/2021
• 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