MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS APEX OPTIFIT HUMERAL STEM, 10MM; SHOULDR PROSTH, REVERSE CONFIG

Model Number	UNIVERS APEX OPTIFIT HUMERAL STEM, 10MM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via phone that an ar-9100-10m apex optifit humeral stem screw was cross threaded.This occurred during a total shoulder replacement on (b)(6) 2024 when the implant was placed in the humerus, and the driver would not engage with the interior screw as it was cross threaded or had something going on that would not allow the driver to engage.The implant was switched out to an ar-9100-11m was used to proceed with the case.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged ar-9100-10m batch number 15155378 was received for investigation.The device was received with other mating part attached to it and was not possible to separate them.Visual evaluation found signs of wear.A visual inspection of the locking screw using a magnifier revealed that the screw was overly tightened, preventing the inclination block from moving to 140°.The port failure is most likely due to user error, specifically the overtightening of the inclination screw, which renders the device inoperative.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.Additional information was provided on 05/22/2024, where the sales representative stated that the patient's bone quality was softer than usual, which is why they switched to a stem as opposed to an eclipse cage screw.The fit of the implant was very solid.Apex broach handles were used to prepare the bone socket.
Event or Problem Description
Additional information was provided on 05/22/2024, where the sales representative stated that the patient's bone quality was softer than usual, which is why they switched to a stem as opposed to an eclipse cage screw.The fit of the implant was very solid.Apex broach handles were used to prepare the bone socket.

• Brand Name: UNIVERS APEX OPTIFIT HUMERAL STEM, 10MM
• 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: 19547285
• Report Number: 1220246-2024-05870
• Device Sequence Number: 4850801
• Product Code: HSD
• UDI-Device Identifier: 00888867404311
• UDI-Public: 00888867404311
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K230513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/17/2024

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: UNIVERS APEX OPTIFIT HUMERAL STEM, 10MM
• Device Catalogue Number: AR-9100-10M
• Device Lot Number: 15155378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: 09/10/2024; 05/22/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 09/18/2024; 12/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown