MAUDE Adverse Event Report: ARTHREX, INC. 5.5X16MM PERIPHERAL SCREW, LOCKING; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	5.5X16MM PERIPHERAL SCREW, LOCKING
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/29/2020
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 through the surgical outcome system that a patient had undergone a shoulder procedure (b)(6) 2020.The following arthrex products were implanted at the time of original surgery: part number ar-9560-24-2 lot number 7266.Part number ar-9561-20p lot number 7181.Part number ar-9562-20nl lot number 2018001453.Part number ar-9562-24nl lot number 2019001012.Part number ar-9563-16 lot number 2019004170.Part number ar-9563-16 lot number 2019003483.Part number ar-9564-2436-lat lot number 19.03388.The patient is scheduled to have a second surgery (b)(6) 2020.Updated information provided 10/30/20: the patient began experiencing pain approximately 4 weeks prior to the report to arthrex.Serial x-rays diagnosed glenoid baseplate loosening.The revision surgery took place (b)(6) 2020 as scheduled.During the revision surgery all original arthrex products, listed in the initial report, were explanted.Once the baseplate was removed, another manufacturer's baseplate, peripheral screws and glenosphere were implanted.Several culture were taken and sent for rapid test to the lab.Rapid test results returned indicating less than 1 neutrophil.Arthrex sales rep who was present states the surgeon did voice concern of the lack of bony ingrowth on the backside of the baseplate.Updated information provided 11/2/20: explanted devices were sent to the facility pathology department.The pathology department does not release devices without patient approval.At this time devices will not be returned.

• Brand Name: 5.5X16MM PERIPHERAL SCREW, LOCKING
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10861824
• Report Number: 1220246-2020-02351
• Device Sequence Number: 2602103
• Product Code: PHX
• UDI-Device Identifier: 00888867296800
• UDI-Public: 00888867296800
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K173900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/18/2020

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: 08/31/2024
• Device Model Number: 5.5X16MM PERIPHERAL SCREW, LOCKING
• Device Catalogue Number: AR-9563-16
• Device Lot Number: 2019003483
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 11/18/2020
• 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