MAUDE Adverse Event Report: ARTHREX, INC. IMPLANT DELIVERY SYSTEM, TRIM-IT SPIN PIN; PIN, FIXATION, SMOOTH

Catalog Number AR-4156DS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 01/01/2011

Event Type  Injury  

Event Description

It was reported in a medwatch that the arthrex trim it pins used in a hammer toe surgery in 2011 did not dissolve as they were supposed to.The result has been on-going pain for 3 years.Patient claimed she went for pain relief consultation.Follow-up information: the patient had the original hammer toe surgery in 2011.During 2013-2014, she has had ongoing pain in her left foot, making it very painful to walk.The patient returned to the surgeon who performed an x-ray, showing a mass in her toes.She was not conformable with this surgeon and sought out a 2nd and 3rd opinion.She decided on a new surgeon who performed a revision surgery in (b)(6) of 2014.She had the pins removed and the two toes in the left foot were shortened due to the amount of bone removed during the revision.The pins were sent out for pathology testing.The tests came back normal.The procedure was completed by placing rods in her toes.Follow up in the 1st week of august, the patient was placed in a walking boot.She stated she cannot walk due to issues with her left foot.

Manufacturer Narrative

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 requested for evaluation but was not returned, 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.Lot number was not provided so device history record review cannot be performed.Absorption of biodegradable implants begins at implantation as a result of normal hydrolysis of the implant.The rate at which the implant degrades and is reabsorbed can be affected by numerous factors including, but not limited to implantation site vascularity, stress on the implants, surgical techniques employed during implantation, patient factors (such as age, immune system status, bone quality, body chemistry and sensitivity to implant materials), and patient post-op compliance to rehabilitation protocols.There is no minimum or maximum established resorption rates for bio-absorbable implants.Bio-absorbable implants are designed with material qualities required to maintain necessary properties throughout the healing process under normal patient conditions.Product directions for use warns of possible foreign body and allergic-like reactions to the implant materials.Patient sensitivity to device materials must be considered prior to implantation.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.Unknown device disposition.

• Brand Name: IMPLANT DELIVERY SYSTEM, TRIM-IT SPIN PIN
• 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: 4039882
• MDR Text Key: 4902667
• Report Number: 1220246-2014-00150
• 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: Company Representative,Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 07/31/2014

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 Catalogue Number: AR-4156DS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/31/2014
• Initial Date FDA Received: 08/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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