MAUDE Adverse Event Report: ENCORE MEDICAL L.P DJO EMPOWR KNEETM, SZ 9, 4-IN-1 CUT BLOCK 2; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	800-05-089
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/28/2023
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
Instrument failure - surgery not completed as intended/suitable device not available.
Additional Manufacturer Narrative
The agent reported "the distal cut is flush with the course, but the anterior chamfer is larger than tolerable." this event occurred during surgery, near the patient.No response was received from the surgeon.Agent will continue to request a response.The surgery was not completed as intended.The instrument was not inspected prior to use.The agent was present during surgery and was not able to source a suitable replacement device.Rma examination: the reported instruments were not returned to djo surgical for evaluation per the product feedback form.No further evaluation can be made for this event.This customer complaint will be closed.If the instruments are returned later, an amendment will be opened.The revision level or lot numbers were not reported; therefore, these instruments 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 and there were no indications that this instrument has a design or material deficiency.The root cause of this complaint is difficult to determine since the device was not returned for evaluation.This is not an event associated with a product failure, malfunction, or issue.

• Brand Name: DJO EMPOWR KNEETM, SZ 9, 4-IN-1 CUT BLOCK 2
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• 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: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 18585127
• Report Number: 1644408-2024-00044
• Device Sequence Number: 8203170
• Product Code: FZX
• UDI-Device Identifier: 00190446255819
• UDI-Public: 00190446255819
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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): 01/25/2024

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: 800-05-089
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2023
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 800-05-309 LOT: UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male