MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; GLENOID HEAD INSERTER/IMPACTOR

Catalog Number	804-03-051
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Complaint - the glenosphere inserter cold welded to the glenosphere trial causing a 30 minute delay in surgery.
Additional Manufacturer Narrative
See h4, h6, and h11."the agent reported "the glenosphere inserter cold welded to the glenosphere trial." item number: 804-03-051, item description: glenoid head inserter/impactor, part revision: c, lot# 324827l01, mfg date: 24-mar-2020, product type: shoulder, possible time in service: 5 years, 10 months, 10 days.This event occurred during surgery, near the patient.No risk or adverse event was reported by the surgeon.The surgery was not completed as intended, and there was a thirty-minute delay.The instrument was inspected prior to use and was deemed acceptable for use based on its appearance.The agent was present during surgery and was able to source a suitable replacement device.Product feedback form sec.D-4 noted ""yes"" for the return of the instrument.However, the reported instrument was not returned to enovis surgical for evaluation.No further evaluation can be made for this event.This customer complaint will be closed.If the device is returned later, the complaint will be updated." the root cause of this complaint was the glenosphere inserter cold welded to the glenosphere trial, likely due to the mechanical binding between metal surfaces.Contributing factors include: 1.Excessive force or over-orquing, which can cause the inserter and trial to seize together.2.Material-to-material friction (galling) between similar metals under pressure.3.Debris or contamination-]such as blood, tissue, or dried fluids-trapped between the mating surfaces.4.Misalignment during assembly, causing edges to catch and bind.5.Surface damage, such as scratches or burrs, that increases friction and promotes sticking.Device history: a review of the device history record(s) show that the reported component(s) used in the previous surgery, 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.Containment: there are no indications that the instrument has a design or material deficiency.Therefore, no containment of inventory is required.Event is associated with instrument usage, not a design or manufacturing issue.Device history records review: a review of the instrument's device history record(s) revealed, when released for use, met design and manufacturing requirements.There were no ncmrs associated with the production of the instrument that is related to the reported issue.

• Brand Name: DJO SURGICAL
• Common Device Name: GLENOID HEAD INSERTER/IMPACTOR
• 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: 24503749
• Report Number: 1644408-2026-00270
• Device Sequence Number: 13376175
• Product Code: HWA
• UDI-Device Identifier: 00888912148184
• UDI-Public: 00888912148184
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: E241504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2026

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 Catalogue Number: 804-03-051
• Device Lot Number: 324827L01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 804-06-340, LOT: 447311L02.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Male