MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,BIOCRKSCRW,FT,VENT; SCREW, FIXATION, BONE

Model Number	SUTR ANCH,BIOCRKSCRW,FT,VENT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/18/2019
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, by an infectious disease physician, that a patient had undergone a shoulder procedure (b)(6) 2019.Patient began having issues within a few weeks post shoulder surgery and has been diagnosed with early onset recurring shoulder infection.Cultures confirmed t-acnes and patient has been treated during last year with ongoing suppressive antibiotics.No decision has been made at this time to explant the devices.The following are the patient's implants: ar-1927bft, bio-corkscrew ft, lot 10218944 (qty 1) and lot 10302639 (qty 1), ar-1926b.Bio-pushlock, lot 10298187 (qty 2).

• Brand Name: SUTR ANCH,BIOCRKSCRW,FT,VENT
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10808368
• Report Number: 1220246-2020-02322
• Device Sequence Number: 14488507
• Product Code: HWC
• UDI-Device Identifier: 00888867023482
• UDI-Public: 00888867023482
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/09/2020

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: 03/31/2021
• Device Model Number: SUTR ANCH,BIOCRKSCRW,FT,VENT
• Device Catalogue Number: AR-1927BFT
• Device Lot Number: 10302639
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 11/09/2020
• 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