MAUDE Adverse Event Report: ARTHREX, INC. UNIVERSAL GLENOID - INLAY LARGE; SHOULDR PROSTH, REVERSE CONFIG

Model Number	UNIVERSAL GLENOID - INLAY LARGE
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 05/22/2024, it was reported by a sales representative via email that an ar-9121-06 arthrex universal glenoid and two ar-9121-03 arthrex universal glenoid would not press onto the baseplate.The baseplate was also swapped out and attempted with the arthrex universal glenoid, but it still would not hold.The case was completed as a reverse procedure on (b)(6) 2024.
Event or Problem Description
Additional information received on 7/23/2024: the intended procedure was an anatomic shoulder with a universal convertible baseplate but since the arthrex universal glenoid would not press onto the baseplate, the surgeon completed the case as a reverse procedure.The case was not delayed, and additional anesthesia was not needed.The patient suffered no negative effects on or after the procedure.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is confirmed.One ar-9121-03, universal glenoid, was received for investigation.Visual evaluation noted that the device had nicks on the edges and damage on the peg.Functional testing was not performed due to the damage of the device.The device's dimensions are congruent to the specifications of drawing c070137.The most likely cause for the reported failure can be attributed to wear and tear due to excessive user-applied mechanical forces over time.

• Brand Name: UNIVERSAL GLENOID - INLAY LARGE
• 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: 19579895
• Report Number: 1220246-2024-06310
• Device Sequence Number: 12610586
• Product Code: PHX
• UDI-Device Identifier: 00888867057432
• UDI-Public: 00888867057432
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K182039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2024

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 Model Number: UNIVERSAL GLENOID - INLAY LARGE
• Device Catalogue Number: AR-9121-03
• Device Lot Number: 22.03262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: Not provided; 09/17/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 08/19/2024; 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown