MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMPOSITE INTERFERENCE SCREW CANNULATED DELTA TAPERED 11X35MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	AR-5035TC-11
Health Effect - Clinical Codes	Unspecified Infection (1930); Fungal Infection (2419)
Date of Event	01/06/2017
Type of Reportable Event	Serious Injury
Additional 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 for evaluation but remained in the patient, therefore the complainant's event could not be verified.Device history record review revealed nothing relevant to this event; no issues were found with the sterilization of this lot.This device is supplied sterile.Based on the information provided, a definitive cause for the post-operative infection could not be determined.The most likely cause for this type of event is a nosocomial source or patient non-compliance with post-op wound care directions.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.
Event or Problem Description
It was reported that the ar-1588-20 retrobutton ((b)(4)) along with the ar-5035tc-11 11 mm x 35 mm delta tapered biocomposite interference screw ((b)(4)) were being used in a knee procedure that took place on (b)(6) 2016.The procedure was completed successfully.The patient developed an infection in the knee after the surgery and was brought back in on (b)(6) 2017 to do a wash out.A culture was performed and found the presence of aspergillus (a fungus).Post op x-rays were also taken at this time.According to the surgeon, the patient may have to come back to have a second surgery.Update:01/27/2017- rep stated that the patient was discharged and facility infection control is looking into this incident.No other surgeries have been scheduled.

• Brand Name: BIO-COMPOSITE INTERFERENCE SCREW CANNULATED DELTA TAPERED 11X35MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6300544
• Report Number: 1220246-2017-00011
• Device Sequence Number: 810797
• Product Code: MAI
• UDI-Device Identifier: 00888867035522
• UDI-Public: 00888867035522
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K071176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2017

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: 09/01/2017
• Device Catalogue Number: AR-5035TC-11
• Device Lot Number: 401163
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2017
• Initial Report FDA Received Date: 02/03/2017
• 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