MAUDE Adverse Event Report: ARTHREX, INC. 35MM CENTRAL SCREW, MODULAR; SHOULDR PROSTH, REVERSE CONFIG

Model Number	35MM CENTRAL SCREW, MODULAR
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 06/01/2022, it was reported by a sales representative via sems that an ar-9560-24-4 24mm +4 lat baseplate and an ar-9561-35s central screw were damaged, the surgeon would not use them.This was discovered during use with no impact to the patient.Additional information has been requested.On 06/13/2022, the sales representative provided the following information via email: this event occurred during a reverse total shoulder procedure.The implant was properly compressed and the morse taper engaged prior to inserting, the implant was then placed on the inserter and as he was tightening the baseplate and making his final turn the actual baseplate become disengaged from the central screw portion.The central screw seated properly before pressing and the surgeon showed the sales representative the line between min and max on the press before releasing, then inserting.They were inserting into the glenoid and it was hard bone but the proper implantation steps were made prior to implanting.Proper technique steps were done to prepare the bone socket for insertion of the implant, pin placed, baseplate reamer used, peripheral reamer was used, the 10mm opening drill was drilled to the positive stop, followed by the appropriately sized tap for that 35mm screw.The surgeon didn't feel confident in trying to put those back together a second time so 2 new implants were opened, there were no other difficulties with the case, and the next baseplate was implanted perfectly.Both devices are available for return and will be returned.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint confirmed.One unpackaged ar-9561-35s screw was received for investigation.Visual inspection identified severe damage along the inner diameter of the returned screw, likely as a result of over-engagement during use with mating instrumentation.Minor thread damage was observed, additionally.The most likely cause for the reported failure can be attributed to wear and tear.

• Brand Name: 35MM CENTRAL SCREW, MODULAR
• Common Device Name: SHOULDR PROSTH, REVERSE CONFIG
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19359222
• Report Number: 1220246-2024-03576
• Device Sequence Number: 12366022
• Product Code: PHX
• UDI-Device Identifier: 00888867296589
• UDI-Public: 00888867296589
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K173900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: 35MM CENTRAL SCREW, MODULAR
• Device Catalogue Number: AR-9561-35S
• Device Lot Number: 7270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown