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

Model Number	800-05-025
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument failure - 1.5 hour 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 (a portion of plastic tip of secondary femoral impactor sheared off during impaction.Surgeon unable to locate plastic piece upon realizing the situation.Surgeon had not completed full closure of knee.Piece located on floor.Surgeon removed suture in place to inspect knee.Liner exchanged.Patient closed and case completed.Age-60/gender -male.) this event occurred during surgery, near the patient.Significant adverse event was reported by the surgeon.The surgery was completed as intended, with a one-and-a-half-hour 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.The instrument was returned to djo and after further examination, the plastic part of the instrument sheared off.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 ncmrs associated with the production of this instrument.Complaint database review shows 87 prior complaints filed against the instruments' item number that reports a similar failure (photos attached).The reported lot is of an old revision.S303 - broke/cracked/damaged, 87.S102 - dull/worn, 1.The root cause of this complaint was likely placement of the impactor under a sharp edge can lead to notching and stress concentration.Additional impaction may lead to breakage.

• Brand Name: DJO EMPOWR KNEETM, FEMORAL IMPACTOR HEAD
• Common Device Name: IMPACTOR
• 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: 17243842
• Report Number: 1644408-2023-00844
• Device Sequence Number: 5260453
• Product Code: HWA
• UDI-Device Identifier: 00888912408707
• UDI-Public: 00888912408707
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: E241504
• 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): 09/08/2023

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 Model Number: 800-05-025
• Device Catalogue Number: 800-05-025
• Device Lot Number: 261492L01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2023
• Supplement Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2018
• 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: 60 YR
• Patient Sex: Male