MAUDE Adverse Event Report: ZIMMER CAS ROSA KNEE ROBOTIC UNIT US PL B; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation logs were provided and reviewed by a rosa engineer.The logs show a robotic error was encountered while in collaborative mode in the femur distal flow, confirming the reported event.The error could be recovered and a few femur distal flow was initiated, but the same error was encountered again in collaborative mode.Multiple collision errors were also seen in the logs, but all cuts seem to have been completed with rosa, along with the final knee evaluation.Review of the hsdk logs shows an error message indicating that a ft (force torque) sensor disconnection was detected.The cause of the robotic and collision errors in this complaint was most likely due to a defective hardware component.There were no software anomalies identified in the logs which would have caused or contributed to the reported events.Field service engineer (fse) was on site for corrective maintenance.Fse found fluctuation in gauge and fx values when applying pressure on the ft sensor cable near the plug.The cable was replaced, but the fluctuations could still be seen.As such, the ft sensor was replaced.Following the replacement of the ft sensor, the fluctuations halted.The device then passed arm accuracy, ati testing, and all applicative tests and was released for clinical use.A review of the device history records and servicing history for the device did not identify any related deviations or contributory factors.It was determined that the cause of the robotic errors was related to a hardware failure.However, a definitive root cause of the hardware failure 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 or Problem Description
It was reported during a rosa knee procedure that the unit presented an unknown robotic error.The cord going into the force sensor seemed loose.After the procedure, the unit¿s power went out.No patient harm, involvement, impact or injury.No additional information.

• Brand Name: ROSA KNEE ROBOTIC UNIT US PL B
• Common Device Name: 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: 18101062
• Report Number: 0009617840-2023-00018
• Device Sequence Number: 7633953
• Product Code: OLO
• UDI-Device Identifier: 00889024511170
• UDI-Public: (01)00889024511170(11)220914
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K210121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/08/2023

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: N/A
• Device Catalogue Number: 20-8020-110-01
• Device Lot Number: 1.4.1.14
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Patient Sex: Unknown