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

Catalog Number AR-4151DS

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Pain (1994); Swelling (2091); Discomfort (2330); No Code Available (3191)

Event Date 06/19/2014

Event Type  Injury  

Event Description

It was reported that patient had left foot surgery on (b)(6) 2013 at which time an arthrex trim-it drill pin was inserted.(per medical records: procedures performed were revision of lower leg tendon, correction of bunion, repair of hammertoe and removal of foot lesion.) patient continued to experience extreme discomfort and had several exams and mri tests performed by original surgeon as well as another podiatric surgeon for a second opinion.Mri's showed no irregular findings and the source of patient's discomfort was unable to be detected.Patient's pain continued and patient sought third opinion from another podiatric surgeon who recommended patient start physical therapy.Patient foot became inflamed and patient was diagnosed to have a mass of some type in her foot.The third surgeon performed surgery on (b)(6) 2014 to remove what he believed to be a mass, but instead found that the arthrex drill pin was still in patient foot and had never absorbed.Trim it drill pin was removed by surgeon.Reporter further states that patient continues to have stabbing nerve pain in the area affected by the product which interferes with patients daily routine.

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device was not returned for evaluation therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.Bio-absorbable implants are designed with material qualities required to maintain necessary properties throughout the healing process under normal patient conditions.The most likely cause of this type of event is an adverse reaction of the patient to the material(s) implanted.Product directions for use warns of adverse effects like foreign body and allergic-like reactions as well as infections both deep and superficial to the implant materials.Patient sensitivity to device materials must be considered prior to implantation.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.

• 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 194
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer Contact: vik bajnath, sr. mdr analyst. ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 4627477
• MDR Text Key: 20972585
• Report Number: 1220246-2015-00070
• Device Sequence Number: 1
• Product Code: HTY
• 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: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2015

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: 05/01/2014
• Device Catalogue Number: AR-4151DS
• Device Lot Number: 522214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2015
• Initial Date FDA Received: 03/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2012
• 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