MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JUNI 2 IN 1 FEM BLK RM SZ 3; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	74013463
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that rust was found in the cutting block before the surgery started.The tech sent the case to safety processing and infectious control.Hospital has requested to replace the item affected and will not process trays until replaced.Procedure was completed without delay with the same device.
Additional Manufacturer Narrative
The device, intended use in treatment, was not returned for evaluation.The photo provided confirmed the juni 2 in 1 fem blk rm sz 3 shows discoloration.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: JUNI 2 IN 1 FEM BLK RM SZ 3
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10183435
• Report Number: 1020279-2020-02656
• Device Sequence Number: 10984716
• Product Code: HSX
• UDI-Device Identifier: 03596010630049
• UDI-Public: 03596010630049
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K113038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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 Model Number: 74013463
• Device Catalogue Number: 74013463
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1