MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP INTERF SCREW CANN DELTA TAP 9 X 35MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number AR-5035TC-09

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Cyst(s) (1800); Swelling (2091)

Event Date 05/25/2015

Event Type  Injury  

Event Description

It was reported that the patient had undergone an acl reconstruction on (b)(6) 2010 with no issues.On (b)(6) 2015, patient came in with complaint and swelling under tibia incision.There was no injury that patient could recall.Physician ordered an mri.The mri came back, showing a cyst around the screw and extending out of tibial tunnel under the tibial skin incision.Physician will be performing an irrigation and debridement and will be removing any remaining screw portion that may not have absorbed but this has not been scheduled as yet.

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, 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 for evaluation but part remains in the patient and cannot be 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.Device history record review revealed nothing relevant to this event.Based on the information provided, the most likely cause(s) of this 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.Part remained in patient.

• Brand Name: BIO-COMP INTERF SCREW CANN DELTA TAP 9 X 35MM
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: 4861425
• MDR Text Key: 16851922
• Report Number: 1220246-2015-00162
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071176
• 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: 06/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2012
• Device Catalogue Number: AR-5035TC-09
• Device Lot Number: 289173
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2010
• 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