MAUDE Adverse Event Report: ARTHREX, INC. IMPLANT SYSTEM, MPFL, BIOCOMPOSITE; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	IMPLANT SYSTEM, MPFL, BIOCOMPOSITE
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	08/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported the patient developed an infection after a medial patella femoral tendon with allograft procedure on (b)(6) 2020.During the (b)(6) 2020 procedure the following arthrex product was implanted: ar-1360c-cp (lot 10435919).In addition, a jrf versagraft (vrg-oo1) was used.The patient developed an infection and on (b)(6) 2020 the surgeon went back in and removed the implant and graft.Surgeon then cleaned and drained the wound.Cultures were taken at the time of second surgery and no new products were implanted.Patient we continue to be observed during the healing process to insure the wound heals and remains free of infection.The culture results were positive for (b)(6).

• Brand Name: IMPLANT SYSTEM, MPFL, BIOCOMPOSITE
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10443132
• Report Number: 1220246-2020-02083
• Device Sequence Number: 19446046
• Product Code: MAI
• UDI-Device Identifier: 00888867014015
• UDI-Public: 00888867014015
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/24/2020

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: 10/31/2021
• Device Model Number: IMPLANT SYSTEM, MPFL, BIOCOMPOSITE
• Device Catalogue Number: AR-1360C-CP
• Device Lot Number: 10435919
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 08/24/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other