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	03/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The agent reported, "baseplate inserter cross threaded during impaction - inserter was stuck to glenosphere.All components including baseplate were ripped out as one piece.Surgery was completed as intended with new baseplate / sphere.Male 66." item number: 804-06-332.Item description: glenoid head inserter/impactor.Lot#: unknown.Part revision:na.Product type: shoulder.Manufacture date: unknown.Possible time in service: unknown.This event occurred during surgery, near the patient.The surgeon reported no risk or adverse event.The surgery was completed as intended, with two hours delay.The instrument was inspected prior to use and deemed acceptable based on its appearance.The agent was present during surgery and was able to source a suitable replacement device.Rma examination: 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.Root cause: "the root cause of this complaint is that the baseplate inserter cross threaded during impaction, resulting in the inserter becoming mechanically bound to the glenosphere.Due to the cross threaded engagement, the inserter could not be disengaged as intended, and the baseplate, glenosphere, and inserter were removed together as a single assembly.As a result, all implanted components were unintentionally extracted.This condition is likely due to misalignment of the inserter threads during initial engagement and subsequent impaction, which resulted in cross threading and mechanical binding under applied force.Based on the investigation and information available, no evidence of a product defect or malfunction was identified.The event appears to be associated with surgical technique during component engagement rather than a product failure.The procedure was subsequently completed as intended using a new baseplate and glenosphere." containment: there are no indications that the instrument has a design or material deficiency.Therefore, no inventory containment is required.The event is associated with instrument usage, not a design or manufacturing issue.Device history records review: the revision level or lot number were not reported; therefore this instrument could not be linked to a specific device history record (dhr) or the actual date of manufacture could not be determined with confidence.Complaint history: the customer complaint history for the reported device(s) showed no current trends or ongoing issues that require review.
Event or Problem Description
Intrument failure - baseplate inserter cross threaded during impaction - inserter was stuck to glenosphere.All components including baseplate were ripped out as one piece.Surgery was completed as intended with new baseplate, 2 hour delay in surgery.

• 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: 24906084
• Report Number: 1644408-2026-00761
• Device Sequence Number: 15934855
• Product Code: HWA
• UDI-Device Identifier: 00888912148184
• UDI-Public: 00888912148184
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2026

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Male