MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; ALTIVATE REVERSE GLENOID CENTRAL SCREW T20 DRIVER

Catalog Number	804-06-325
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The agent reported "surgeon had to remove more bone to remove the tap out.Resulting in arg with the revision base plate.Then tightening the arg the tip of 804-06-325 broke in the process.".This event occurred during surgery, near the patient.Significant adverse event was reported by the agent.There was a 15 minute delay in surgery but the surgery completed as intended.The device was inspected prior to use and found to be acceptable.The agent was present when this event occurred and was able to provide another suitable device.Rma examination: the reported device was not returned to surgical for evaluation.The product feedback form indicates the device was lost/discarded.If at a later time the device is returned an amendment will be opened.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.It is likely attributable to damage incurred from prolonged use and through misuse or rough handling which surgical instruments are subjected to.This is not an event associated with a product failure, malfunction, or issue.Complaint database review showed no previous complaints that allege this same issue.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.
Event or Problem Description
It was reported that surgeon had to remove more bone to remove the tap out.Resulting in arg with the revision base plate.Then tightening the arg the tip of 804-06-325 broke in the process.

• Brand Name: DJO SURGICAL
• Common Device Name: ALTIVATE REVERSE GLENOID CENTRAL SCREW T20 DRIVER
• 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: 21381557
• Report Number: 1644408-2025-00170
• Device Sequence Number: 15571012
• Product Code: HXX
• UDI-Device Identifier: 00190446844181
• UDI-Public: 00190446844181
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: E337825
• 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): 02/13/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 804-06-325
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male