MAUDE Adverse Event Report: ARTHREX, INC. TRIM-IT DRILL PIN, 1.5MM X 100MM; PIN, FIXATION, SMOOTH

Model Number	TRIM-IT DRILL PIN, 1.5MM X 100MM
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Erythema (1840); Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091)
Date of Event	09/01/2018
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
A patient has reported through the arthrex website that she had undergone surgery in (b)(6) 2018 during which a trim-it pin was implanted.Patient states she has an allergy to acrylic polymers and was inquiring as to the material composition of the implant.Specific arthrex part number was not provided.Patient states the device may be causing a delayed foreign body reaction in the toes that the surgery was performed on.Additional information provided 4/29/2019: date of surgery was (b)(6) 2018.Surgery was a hammer toe procedure of middle toe/right foot.Patient issues first began in (b)(6) 2018.During the 9/19/18 procedure an arthrex ar-4151ds trim it pin was implanted.Symptoms include swelling, redness, pain which generates from patient toe to her calf.To date she has been treated with cortisone shots.Patient is being provided with the material composition of the device as requested.

• Brand Name: TRIM-IT DRILL PIN, 1.5MM X 100MM
• Common Device Name: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8636768
• Report Number: 1220246-2019-01103
• Device Sequence Number: 1992683
• Product Code: HTY
• UDI-Device Identifier: 00888867032781
• UDI-Public: 00888867032781
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K050259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/23/2019

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: TRIM-IT DRILL PIN, 1.5MM X 100MM
• Device Catalogue Number: AR-4151DS
• Device Lot Number: 10181542
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 05/23/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other