MAUDE Adverse Event Report: ARTHREX, INC. IMPLANT SYSTEM, TRIM-IT DRILL PIN, 2X100; PIN, FIXATION, SMOOTH

Model Number	IMPLANT SYSTEM, TRIM-IT DRILL PIN, 2X100
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/02/2021
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
On (b)(6) 2021, it was reported by a patient via e-mail that an ar-4152ds lot:10226124 trim-it drill pin has worked it's was out the incision site from the top of the toe.Patient is seeking a third opinion from a doctor.Additional information requested.

• Brand Name: IMPLANT SYSTEM, TRIM-IT DRILL PIN, 2X100
• Common Device Name: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12507086
• Report Number: 1220246-2021-03682
• Device Sequence Number: 11607072
• Product Code: HTY
• UDI-Device Identifier: 00888867032811
• UDI-Public: 00888867032811
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K050259
• 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): 09/21/2021

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 Expiration Date: 06/30/2020
• Device Model Number: IMPLANT SYSTEM, TRIM-IT DRILL PIN, 2X100
• Device Catalogue Number: AR-4152DS
• Device Lot Number: 10226124
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 09/21/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other