MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP INTERFERENCE SCREW; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	AR-1390C
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/27/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (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 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 cause of the event could not be determined from the information available and without device evaluation.The most likely cause of this type of event is a reaction of the patient to the material(s) implanted.Patient sensitivity to device materials must be considered prior to implantation.Device history record review revealed nothing relevant to this event.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.Per customer, device will not be returned.
Event or Problem Description
It was reported that there was a failure of 5 degree extension and pain.The knee is stable.During the second surgery, a culture sample was sent for analysis.Without the laboratory results, a clinical result was diagnosed by surgeon; indicating there were no signs of infection.Patient has no known allergies, is a non-smoker, is not lactose intolerant and has thrombocytopenic purpura with permanent treatment.No medical treatment was given because there were no results from previous cases.On (b)(6) 2016, a second arthroscopic surgery took place with neo-ligament.Indemnity with fibrosis graft (cyclops) to dry, and a minimal notch of plastia.It was incised on previous scar located in the tibial tunnel with remains of white clumpy white screw.There was no type of bio-integration, curetted the area, and the material sample was sent to pathology (there were no signs of clinical infection) the tunnel was cleaned and not to be filled.The remains of the implant was retrieved from patient.The original surgery took place on (b)(6) 2014.

• Brand Name: BIO-COMP INTERFERENCE SCREW
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 5828805
• Report Number: 1220246-2016-00311
• Device Sequence Number: 16206004
• Product Code: MAI
• UDI-Device Identifier: 00888867015517
• UDI-Public: 00888867015517
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K071176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 07/07/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2016
• Device Catalogue Number: AR-1390C
• Device Lot Number: 1189208
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2016
• Initial Report FDA Received Date: 07/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 22 YR