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

Device Problem Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 09/02/2021

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

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
• Type of Device: PIN, FIXATION, SMOOTH
• 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: 12507086
• MDR Text Key: 272642199
• Report Number: 1220246-2021-03682
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867032811
• UDI-Public: 00888867032811
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050259
• 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: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 09/02/2021
• Initial Date FDA Received: 09/21/2021
• Date Device Manufactured: 07/24/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other