MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS SPACER 36+9MM; SHOULDR PROSTH, REVERSE CONFIG

Model Number	UNIVERS REVERS SPACER 36+9MM
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2024
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 4/19/2024, it was reported by a sales representative via email that an ar-9555-09 univers revers spacer was loose after implantation.The ar-9501-06s univers revers apex stem and ar-9502f-36cpc univers revers suturecup attached perfectly fine in the assembly block.The ar-9555-09 univers revers spacer was placed in the patient, and the appropriate driver was used to tighten the assembly screw.Appropriate torque was applied, and an ar-9503s-03 univers revers humeral insert was impacted.Once the univers revers humeral insert was impacted, it was observed that the univers revers spacer had, in fact, somehow remained loose.The entire construct needed to be removed because the univers revers spacer could not be disassociated from the univers revers suturecup.The surgery outcome was not impacted, and the surgeon was able to complete the surgery with replacements we had available.The patient was not affected.This was discovered during an apex stem construct procedure.Additional information received on 4/25/2024: the case was delayed only between ten to fifteen minutes.Additional anesthesia was unnecessary, and the patient suffered no negative effects.
Additional Manufacturer Narrative
The complaint allegation was confirmed.One unpackaged ar-9555-09 batch, 20.01015, was received for evaluation.The device, along with additional components, has been received for investigation.Visual inspection revealed scratches on the surface of the device.During the functional testing of the ar-9503s-03, resistance was encountered due to damage to the hex of the central screw.The screw was found to be cross-threaded, and a fragment of the thread detached when the screw was removed.The most likely cause of the reported failure seems to be user error, as the visible damage to the screw indicates that it was not seated flush, preventing the cup from being properly set.

• Brand Name: UNIVERS REVERS SPACER 36+9MM
• 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: 19329981
• Report Number: 1220246-2024-03376
• Device Sequence Number: 20583776
• Product Code: PHX
• UDI-Device Identifier: 00888867062481
• UDI-Public: 00888867062481
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K142863
• 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,Followup
• Report Date (Section B): 09/13/2024

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: 04/30/2025
• Device Model Number: UNIVERS REVERS SPACER 36+9MM
• Device Catalogue Number: AR-9555-09
• Device Lot Number: 20.01015
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown