MAUDE Adverse Event Report: ENCORE MEDICAL L.P. IMPACTOR; DJO EMPOWR KNEETM, IMPACTOR HANDLE

Catalog Number	800-05-024
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Event or Problem Description
Instrument failure - using handle to impact the femur, the button broke.
Additional Manufacturer Narrative
Corrected data: the record has now been determined it is not a reportable event per company assessment.Additional reporting on this event will not be provided.

• Brand Name: IMPACTOR
• Common Device Name: DJO EMPOWR KNEETM, IMPACTOR HANDLE
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin, tx 78758-5445
• MDR Report Key: 11934161
• Report Number: 1644408-2021-00485
• Device Sequence Number: 11809185
• Product Code: HWA
• UDI-Device Identifier: 00888912408691
• UDI-Public: (01)00888912408691
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: E241504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 800-05-024
• Device Lot Number: 332158L05
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 54 YR
• Patient Weight: 118