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

Model Number	N/A
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, robotic unit remains at hospital and will be evaluated by engineer.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text : robotic unit remains on site.
Event or Problem Description
It was reported patient underwent an initial rosa left knee arthroplasty.During the case, rosa gave a constant "force collision error detected" with no force on the arm.Subsequently, case was canceled and patient was woken up from anesthesia.Case was rescheduled.No additional information on the reported event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated updated: g3; h2; h3; h6.Physical and technical evaluation was performed by a field service engineer (fse), and confirmed the appearance of unknown robotic errors that could not be resolved by multiple restarts.A log inspection discovered a disconnection of the force torque sensor from the arm related to the cable.The fse decided to replace the f/t sensor cable with one from a demo unit, and the errors were resolved.The fse went on to replace the f/t sensor as well and performed an arm accuracy and applicative test to ensure proper function.The unit was fully operational after repairs.Device history record (dhr) was reviewed and no deviations or anomalies were discovered.With the information currently available, a root cause for the malfunction of the force torque sensor and the force sensor cable resulting in disconnections cannot be definitively determined.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
No additional information on the reported event.

• 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: 16885277
• Report Number: 0009617840-2023-00007
• Device Sequence Number: 6312233
• Product Code: OLO
• UDI-Device Identifier: 00889024511170
• UDI-Public: (01)00889024511170(11)220427
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 20-8020-110-01
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2023
• Supplement Date Received by Manufacturer: 07/03/2023
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Male