MAUDE Adverse Event Report: ENCORE MEDICAL L.P. IMPACTOR HEAD; DJO EMPOWR KNEETM, FEMORAL IMPACTOR HEAD

Model Number	800-05-025
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2022
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
Revision surgery - during impacting of the femoral implant, the impactor tip disassociated from the metal base.
Additional Manufacturer Narrative
The reason for this instrument failure was reported as disassociation.The possible time in service for baseplate is 5.2 years from manufactured date.Initial or prolonged hospitalization was required.The healthcare professional indicated this event occurred during surgery, near the patient.The device was not returned to manufacturer and made available at djo surgical for examination.A review of 800-05-025 device history record (dhr) revealed the instrument, when released for use, met design and manufacturing requirements.There were no non-conforming material report (ncmr) associated with the production of this instrument.Complaint database review showed 85 previous complaints, there were indications that this instrument has a design or material deficiency.Those are 85 broke/cracked/damaged.The root cause of this complaint is impactor tip disassociated from the metal base.There are no indications that this instrument has a material nonconformance.This issue does not create patient risk; therefore, no containment of inventory is required.The event is associated with instrument usage, not a design or manufacturing issue.Rma examination: the instrument was not returned, it was lost / discarded on site.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: IMPACTOR HEAD
• Common Device Name: DJO EMPOWR KNEETM, FEMORAL IMPACTOR HEAD
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 15455925
• Report Number: 1644408-2022-01251
• Device Sequence Number: 12488242
• Product Code: HWA
• UDI-Device Identifier: 00888912408707
• UDI-Public: (01)00888912408707
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2022

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 Model Number: 800-05-025
• Device Catalogue Number: 800-05-025
• Device Lot Number: 245945L01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2022
• Supplement Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 09/20/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2017
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Male