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

Catalog Number	804-06-332
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	02/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument failure - instrument failure, fragments left in patient.
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
The agent reported "(while implanting a peripheral torx screw, the driver tip broke off in the screw a small portion of the driver is stuck in the screw and not being returned.)." examination confirmed the complaint, the returned instrument shows the tip has broken off, the reported condition could possibly be a result of heavy use, misuse, wear and care must be taken to avoid compromising their performance.This event occurred during surgery near the patient.There was another suitable device available, however, the incident did cause a 1 min.Delay in surgery.The surgery was completed as intended, there was no risk or adverse event reported, and the instrument was inspected prior to surgery and was found to be acceptable.Surgical instruments condition can be determined while being used for its intended purpose.The replacement of surgical instruments due to normal wear and tear does not indicate a product deficiency, failure or issue.No further action is deemed necessary at this time.A review of the device history record (dhr) revealed, when released for use, the item(s) met design and manufacturing requirements.Complaint database review showed previous complaints but there were no indications that this instrument has a design or material deficiency.This is the first complaint against this part/lot number through all failure codes.This event is possibly attributable to damage incurred through misuse or rough handling which surgical instruments are subjected to.This is not an event associated with a product failure, malfunction or issue.

• Brand Name: DJO SURGICAL
• Common Device Name: ALTIVATE REVERSE GLENOID PERIPHERAL 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: 21670662
• Report Number: 1644408-2025-00290
• Device Sequence Number: 4420001
• Product Code: HXX
• UDI-Device Identifier: 00190446844198
• UDI-Public: 00190446844198
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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: 804-06-332
• Device Lot Number: 434215L02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 87 YR
• Patient Sex: Female