MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; DJO EMPOWR REVISION KNEE, 3.5MM BALL END HEX DRIVER

Catalog Number	800-05-093
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
Type of Reportable Event	Serious Injury
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 - surgeon was unable to engage screws through posterior augments into revision femur component.This is due to having to stack 2 augments for a 10mm augment and having a screwdriver capable of allowing the surgeon to place the screw at a proper angle.This continues to be a problem every revision knee surgery creating an unfavorable impression for residents and fellows training on our products.Another screwdriver option needs to be made available or a single piece 10mm posterior femoral augment.20 minute delay in surgery.
Additional Manufacturer Narrative
See d3, g1, h6, and h11.The agent reported "surgeon was unable to engage screws through posterior augments into revision femur component.This is due to having to stack 2 augments for a 10mm augment and having a screwdriver capable of allowing the surgeon to place the screw at a proper angle.This continues to be a problem every revision knee surgery creating an unfavorable impression for residents and fellows training on our products.Another screwdriver option needs to be made available or a single piece 10mm posterior femoral augment".This event occurred during surgery, near the patient.Significant adverse event was reported by the surgeon.There was a 20 minute delay in surgery, and the surgery was not completed as intended.The devices were inspected prior to use and found to be acceptable.The agent was present when this event occurred and was unable to provide another suitable device.The reported devices were not returned to surgical for evaluation.The product feedback form indicates the devices were lost/discarded.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.A review of the device history records (dhr) show for 245-05-145, empowr knee, revision posterior fem augment size 4/5, 5mm, used in the surgery, when released for use, met design and manufacturing requirements.There was ncmr-64375 associated with the 245-05-145, empowr knee, revision posterior fem augment size 4/5, 5mm, which document that out of 40 parts lot, 40 parts were rejected due to the bills of materials for augment part numbers did not include color-coded labels.Later, the rejected part(s) were reworked and accepted after proper justification.All items in the lot met fit, form and function requirements.The devices were verified to have gone through an acceptable sterilization process and were within its expiration date at the time of the surgery.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.This issue only occurs when assembling posterior lateral augments on the smaller size revision femurs.Looking through the dels surveys for revision knee there were 2 surveys mentioning that the posterior augments were difficult to install when being stacked.Both surgeons gave it a rating of 3 which is neutral.At this time, the issue will continue to be monitored.

• Brand Name: DJO SURGICAL
• Common Device Name: DJO EMPOWR REVISION KNEE, 3.5MM BALL END HEX DRIVER
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENOVRE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: stacey bonnell ; 9800 metric blvd; austin, TX 78758 ; 5128346313
• MDR Report Key: 20196523
• Report Number: 1644408-2024-01491
• Device Sequence Number: 7650147
• Product Code: JWH
• UDI-Device Identifier: 00190446750734
• UDI-Public: 00190446750734
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K213793
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 12/11/2024

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: 800-05-093
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 245-05-145 LOT: 2750A1001; 245-05-145 LOT: 2750A1001
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Female