MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW SYSTEM; ALTIVATE REVERSE MODULAR CENTRAL SCREW, 6.5 X 30MM

Catalog Number	508-65-030
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - baseplate and central screw are not fully seating and lock together causing functionality concerns.
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Additional Manufacturer Narrative
See d2a, d4, d10, h4, h6 and h11.The agent reported "baseplate and central screw are not fully seating and lock together causing funionality concerns.Has happened several time and surgeon stated he will not use the system again until resolved." item number: 508-65-030.Item description: altivate reverse modular central screw, 6.5 x 30mm.Part revision: a.Lot#: 5023a1038a.Product type: shoulder.Manufacture date: 12/13/24.Expiration date: 12/9/29.This event occurred post operative.Healthcare professional indicated no risk or adverse event.No delay in surgery was noted.When this event occurred, there was another suitable device available, and the surgery was completed as intended.The device was inspected prior to use and found acceptable.Rma examination: the reported device was not returned to surgical for evaluation.If at a later time the device is returned, an amendment will be opened to evaluate the event.Surgical devices condition can be determined while being used for its intended purpose.This does not indicate a product deficiency, failure or issue.No further action is deemed necessary at this time.Device history: a review of the device history record(s) shows that the reported component(s), when released for use, met design and manufacturing requirements.There were no nonconforming material reports associated with the product(s) that may have contributed to the reported event.The device(s) was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of the surgery.Root cause: the root cause of the complaint is the baseplate and central screw are not fully seating and locking together, likely due to being slightly off axis when seating.This is an event associated with technique, not an event associated with product failure, malfunction, or issue.Complaint history: complaint database review showed previous complaints but there were no indications that this instrument has a design or material deficiency.Containment: inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.The surgery was completed successfully.

• Brand Name: DISCOVERY ELBOW SYSTEM
• Common Device Name: ALTIVATE REVERSE MODULAR CENTRAL SCREW, 6.5 X 30MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: stacey bonnell ; 9800 metric blvd; austin, TX 78758 ; 5128346313
• MDR Report Key: 24000042
• Report Number: 1644408-2026-00042
• Device Sequence Number: 13308012
• Product Code: KWS
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K233481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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 Catalogue Number: 508-65-030
• Device Lot Number: 5023A1038A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 508-65-000 LOT: 5008A1162.; 508-65-030 LOT: 5023A1038A.; 508-65-030 LOT: 5023A1038A.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Female