MAUDE Adverse Event Report: ENCORE MEDICAL L.P DJO EMPOWR KNEETM, SZ 8, 4-IN-1 CUT BLOCK 2; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	800-05-088
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The agent reported that (during a primary total knee: while using a mallet to place the size 8 4 in 1 cut guide on the distal femur, one of the back pegs on the guide sheared off and stayed in the patient's femur.Upon noticing the peg, it was dug out.) his event occurred during surgery, near the patient.Significant adverse event was reported by the surgeon.The surgery was completed as intended, with a thirty-five-minute delay.The instrument was inspected prior to use and was deemed acceptable for use based on its appearance.The agent was present during surgery and was able to source a suitable replacement device.Rma examination: the instrument was returned to djo and after further examination, one of the pegs on the cut block broke.
Event or Problem Description
It was reported there was a 35 minute delay in surgery.

• Brand Name: DJO EMPOWR KNEETM, SZ 8, 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: 19076878
• Report Number: 1644408-2024-00436
• Device Sequence Number: 6272022
• Product Code: FZX
• UDI-Device Identifier: 00190446255802
• UDI-Public: 00190446255802
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: E529269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 04/09/2024

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: 800-05-088
• Device Lot Number: 359744L26
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2022
• 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 Sex: Unknown