MAUDE Adverse Event Report: ARTHREX, INC. BUTTON, DOG BONE; WASHER, BOLT NUT

Model Number	BUTTON, DOG BONE
Health Effect - Clinical Codes	Bacterial Infection (1735); Fatigue (1849); Pain (1994); Pleural Effusion (2010); Sweating (2444); Weight Changes (2607)
Date of Event	06/12/2020
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 that the patient had undergone a revision acl procedure on (b)(6) 2020.During the procedure a lifenet fgl was used.Patient had developed an infection.Surgeon washed out the knee.So far nothing has grown on cultures, but he will have to take the allograft out if the patient doesn¿t get better.The reporter also copied lifenet in on their initial report to arthrex.Graft id: 1913080-1009.Additional information provided on 7/8/2020: the physician reported the patient had a prior acl surgery many years ago (>7) and a revision was performed on (b)(6) 2020.No evidence of any prior osteo or infection in the past.The primary surgery was performed by a different surgeon.The surgeon cannot confirm if arthrex products were used during the primary procedure.The patient decided to have it finally revised, but had been living without their acl for awhile.The index revision acl surgery was on (b)(6) 2020.Washout was performed one week later on (b)(6) 2020.No implants were explanted at the time of the washout.The following arthrex products were implanted during the revision surgery; fgl // graft id: 1913080-1009.Ar-1588tn-1 // lot: 10655198.Ar-1588btb // lot: 10591147.Ar-2270 // lot: 10779787.Following the revision surgery; the patients symptoms were fevers, night sweats and feeling ill, malaise, weight loss, knee pain and effusion.The patient had elevated esr and crp.Some bacteria noted in the cell count but never grew anything from all the multiple cultures.The patient responded better to iv abx with ceftriaxone via a picc line.The patient is doing better, but still having some night sweats.Knee is looking and feeling better.Due to the unusual presentation and lack of culture results, the surgeon and the id consultants are concerned about possible contaminated graft or possible mycobacteria, etc.

• Brand Name: BUTTON, DOG BONE
• Common Device Name: WASHER, BOLT NUT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10308386
• Report Number: 1220246-2020-01966
• Device Sequence Number: 952232
• Product Code: HTN
• UDI-Device Identifier: 00888867026599
• UDI-Public: 00888867026599
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K052276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/22/2020

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: 03/31/2025
• Device Model Number: BUTTON, DOG BONE
• Device Catalogue Number: AR-2270
• Device Lot Number: 10779787
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2020
• Initial Report FDA Received Date: 07/22/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other