MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,2.5 MICRO,18MM LGTH; SCREW, FIXATION, BONE

Model Number COMPR FT SCRW,2.5 MICRO,18MM LGTH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994)

Event Date 07/12/2021

Event Type  Injury  

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 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,2.5 MICRO,18MM LGTH
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 12267142
• MDR Text Key: 264921983
• Report Number: 1220246-2021-03453
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: COMPR FT SCRW,2.5 MICRO,18MM LGTH
• Device Catalogue Number: AR-8725-18H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other