MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO EMPOWR KNEETM TIBIAL TEMPLATE, 9 LEFT; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	801-05-364
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Instrument failure - tibia tray broke when using punching your tibia with punch, left knee, 30 minute delay in surgery.
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 "tibia tray broken when using punching your tibia with punch, left knee." this event occurred during surgery, near the patient.A significant adverse event was reported by the surgeon.There was a 30 minute delay in surgery, and the surgery was completed as intended.The instruments were inspected prior to use and found to be acceptable.The agent was present when this event occurred and able to provide another suitable device.The reported device was returned to surgical for evaluation.The inner square is chipped/broken.A review of the instrument's device history records (dhr) revealed, when released for use, met design and manufacturing requirements.There was a ncmr#(b)(4) associated with the main part # 801-05-364, djo empowr knee tibial template (b)(4) left which document that out of (b)(4) parts lot, (b)(4) part was rejected due to rust-colored spot on the side.Later, the rejected part was dispositioned rtv.All other items in the lot met fit, form and function requirements.Complaint database review showed (b)(4) previous complaints but there were no indications that this instrument has a design or material deficiency.S303 - broke/cracked/damaged, 3.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.The root cause of this complaint 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.

• Brand Name: DJO EMPOWR KNEETM TIBIAL TEMPLATE, 9 LEFT
• 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: 19495039
• Report Number: 1644408-2024-00883
• Device Sequence Number: 18279073
• Product Code: FZX
• UDI-Device Identifier: 00190446239062
• UDI-Public: 00190446239062
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K171991
• 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): 08/07/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 801-05-364
• Device Lot Number: 368285L11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 06/08/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Age: 65 YR
• Patient Sex: Male