MAUDE Adverse Event Report: ENOVRE MEDICAL L.P. DJO SURGICAL; DJO EMPOWR KNEETM, GAP BALANCER, FEM SIZER

Catalog Number	800-05-101
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Instrument failure - broken instrument, pieces left in patient.
Additional Manufacturer Narrative
The agent reported instrument broke while in usage.X-ray found that the instrument was left inside of the patient.This event occurred during surgery near the patient.Healthcare profession indicated significant adverse event reported by the surgeon.There was no delay in surgery and the surgery was completed as intended.The instruments were inspected prior to use and found acceptable.The agent was present when this event occurred and there was another suitable device available.Rma examination: the reported devices was not returned to envois surgical for evaluation due to the instrument being lost or discarded.The lot number was not reported.No further evaluation can be made for this event.The customer complaint will be closed.If the devise is returned later, the complaint will be updated.The revision or lot number were not reported; therefore, this instrument could not be linked to a specific device history record or actual date of manufacture could not be determined with confidence.Database review showed previous complaints but there were no indications that this instrument has a design or material deficiency.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 difficult to determine, since it was not returned for evaluation.It is likely attributable to damage from rough handling.This is not an event associated with a product failure, malfunction, or issue.

• Brand Name: DJO SURGICAL
• Common Device Name: DJO EMPOWR KNEETM, GAP BALANCER, FEM SIZER
• Manufacturer (Section D): ENOVRE 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: 20873934
• Report Number: 1644408-2024-01852
• Device Sequence Number: 8904952
• Product Code: LXH
• UDI-Device Identifier: 00888912408752
• UDI-Public: 00888912408752
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K143242
• 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): 12/07/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 800-05-101
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 12/07/2024
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Male