MAUDE Adverse Event Report: ZIMMER CAS ROSA KNEE OPTICAL UNIT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number N/A

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/07/2023

Event Type  Injury  

Event Description

It was reported that the customer had issues with the rosa camera during the surgery, where it was showing red (meaning error) and stopped working.They tried restarting the system but the problem persisted.The procedure was canceled.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).The device will not be returned for analysis, as the device remains and gets repaired on site; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Physical and technical evaluation was performed by a field service engineer (fse) and confirmed the reported issue that the camera would not function.He observed the camera showing a flashing green light and stable red light.The fse isolated the problem to the power over ethernet (poe) injector and umbilical cord.He replaced both components to ensure power would be delivered to the camera correctly.The functionality of the camera was checked and an application test was performed.The system passed all testing and was fully operational and cleared for clinical use.Review of the device history records/servicing history identified no deviations or anomalies related to the reported event.The cause for the camera power issues was determined to be a failed poe injector.A definitive root cause for the failed component is unable to be determined with the information available.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: ROSA KNEE OPTICAL UNIT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ZIMMER CAS; 75 queen str.; suite 3300; montreal, quebec H3C 2 N6; CA H3C 2N6
• Manufacturer (Section G): ZIMMER CAS; 75 queen str.; suite 3300; montreal, quebec H3C 2 N6; CA H3C 2N6
• Manufacturer Contact: kristen lashley ; 56 e. bell dr.; warsaw, IN 46582 ; 9016334069
• MDR Report Key: 17404747
• MDR Text Key: 319877667
• Report Number: 0009617840-2023-00014
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00889024511323
• UDI-Public: (01)00889024511323(11)201111
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K210121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 20-8020-120-01
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other