MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; EMPOWR ACETABULAR, BONE SCREW, 25MM

Catalog Number	940-00-025
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The agent reported "the tip of the 35mm drill bit for the empowr acetabulum broke off during drilling.Because of the location dr pastore chose to leave it rather cause more harm in trying to get the cup out and create larger bone loss.".This event occurred during treatment, near the patient.There was no risk or adverse event reported by the surgeon.There was a 20 minute delay in surgery, but the surgery was 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.The reported device was not returned to surgical for evaluation.The product feedback form indicates the device was left in the patient.If at a later time the device is returned, an amendment will be opened.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 database review showed no previous complaints that allege this same issue.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 difficult to determine the root cause of this failure since the device was not returned; 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.
Event or Problem Description
Complaint - surgeon was tightening the screw, and the head snapped off.The shaft of the screw remains in the patient and the head was discarded.

• Brand Name: DJO SURGICAL
• Common Device Name: EMPOWR ACETABULAR, BONE SCREW, 25MM
• 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: 21300316
• Report Number: 1644408-2025-00089
• Device Sequence Number: 12783401
• Product Code: LPH
• UDI-Device Identifier: 00190446293439
• UDI-Public: 00190446293439
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K190057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 02/03/2025

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: 940-00-025
• Device Lot Number: 146Z1302
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Male