MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION®DCF 4 IN 1 RSCT GUID ADJUSTABLE SIZE 8; KNEE INSTRUMENT

Model Number	E1204108
Medical Device Problem Codes	Break (1069); Malposition of Device (2616)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, turned the rotating dial on cutting to '0' position.At this point it had malfunction due anterior resection was off and notched the anterior cortex significantly, posterior resection did not align correctly.The cutting block and back plate, spring, and center dial popped out were removed.It was confirmed that due to this instrument breaking, the femoral bone was cut incorrectly leading to a revision of the components in surgery and a 2.5 hour delay.Also, only one set of implants was used in the surgery and they were implanted.

• Brand Name: EVOLUTION®DCF 4 IN 1 RSCT GUID ADJUSTABLE SIZE 8
• Common Device Name: KNEE INSTRUMENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 14348221
• Report Number: 3010536692-2022-00161
• Device Sequence Number: 4155432
• Product Code: FZX
• UDI-Device Identifier: M684E12041081
• UDI-Public: M684E12041081
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2022

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: Other
• Device Model Number: E1204108
• Device Catalogue Number: E1204108
• Device Lot Number: 1323023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/20/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male