MAUDE Adverse Event Report: ARTHREX, INC. TRIM-IT DRILL PIN 2MM X 100MM; PIN, FIXATION, SMOOTH

Catalog Number AR-4152B

Device Problems Device Operates Differently Than Expected (2913); Material Protrusion/Extrusion (2979)

Patient Problem No Code Available (3191)

Event Date 09/21/2015

Event Type  Injury  

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 requested/is expected for evaluation but has not yet been received.The cause of the event could not be determined from the information available and without device evaluation.Device history record review revealed nothing relevant to this event.Based on the information provided, a most likely cause(s) of this event is that 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.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 the device is returned and additional information is obtained, a follow-up report will be submitted.

Event Description

It was reported that the surgeon inserted the implant two years ago and is wondering why the implant was not absorbed after two years.In a second surgery, the pin was removed from the patient and another pin from another manufacturer was used.The surgeon has returned all pins for investigation.Follow-up investigation: the pins were not surgically removed but just pulled out in a second surgery.The bone has fully consolidated but the patient was shocked to the pin sticking out of the toe.

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 received and an evaluation was completed.Device history record review revealed nothing relevant to this event.Complaint not confirmed.No problem found with device upon our evaluation.The type of event described by the complainant may occur when the bone tunnel is not drilled deep enough and the pin is not placed deep enough into the toe.Also, failure to follow the post-operative rehab protocol may also contribute to this type of event.The directions for use states: post-operatively, until healing is complete, the fixation provided by this device should be protected.The post-operative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the implant, otherwise loosening, fracture, or migration of the device may result.In addition, 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.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 the device is returned and additional information is obtained, a follow-up report will be submitted.

• Brand Name: TRIM-IT DRILL PIN 2MM 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, sr. mdr analyst. ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 5154057
• MDR Text Key: 28450557
• Report Number: 1220246-2015-00275
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K050259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2016
• Device Catalogue Number: AR-4152B
• Device Lot Number: 1191096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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