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

Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091); Discomfort (2330)

Event Date 12/21/2016

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 therefore the complainant's event could not be verified.The device remains in patient.The cause of the event could not be determined from the information available and without device evaluation.A possible cause of this type of event may be a reaction of the patient to the material(s) implanted or used during the implant procedure.Product directions for use warns of effects like foreign body and allergic-like reactions as well as infections both deep and superficial to the implant materials.Patient sensitivity to materials must be considered prior to implantation.

Event Description

It was reported that a patient is experiencing pain, swelling and a reported infection since a trim it pin was implanted in (b)(6) 2016.The rep stated that the trim it pin was implanted for a hammertoe correction.Additional information has been requested.Additional information received on 10/10/2018: the rep confirmed that the original procedure took place on (b)(6) 2016.The original procedure was a hammertoe correction procedure on toes, 2, 3, and 4.The following part and lot numbers were implanted during the original (b)(6) 2016 procedure: ar-4151ds: lot: 10048351 / qty.2.Ar-4151ds: lot: 10029027 / qty.1.The rep stated they are not aware of the specific date of when the patient started experiencing pain, swelling, discomfort, and reported infection.The rep reported that they were not given any specifics on type of infection, or if there has been testing done.There are not any details on current treatment for the patient's reported infection and symptoms.The rep stated that the same surgeon who performed the original procedure does plan to remove the pin at the same location of the original surgery.The rep confirmed that as of now there has not been a removal surgery scheduled.The rep stated that they were able to read the operative report.The implant log confirmed that the trim it pins were used on the third and fourth as well.Additional information received on 10/22/2018: the rep confirmed that a total of three ar-4151ds were implanted during the original procedure on toes 2, 3, and 4.The rep confirmed that nothing else was implanted during the original procedure.

• Brand Name: TRIM-IT DRILL PIN, 1.5MM X 100MM
• 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: 8030510
• MDR Text Key: 125907781
• Report Number: 1220246-2018-00724
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867032781
• UDI-Public: 00888867032781
• 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: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: TRIM-IT DRILL PIN, 1.5MM X 100MM
• Device Catalogue Number: AR-4151DS
• Device Lot Number: 10048351
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/10/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/30/2016
• 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