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

Model Number N/A

Device Problem Output Problem (3005)

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

Event Type  malfunction  

Event Description

It was reported spontaneous collision error occurs when rose recon platform is not active.Possible issue with the force sensor.No additional information available.

Manufacturer Narrative

(b)(4).Reported event was confirmed via provided investigation logs.Analysis of the investigation logs confirmed the rosa system generating collision errors while in use.The logs were consistent with ft sensor connection issues.The serial number was reviewed for any deviations and/or anomalies in the servicing/maintenance process that may have contributed to this reported event.No deviations or anomalies were discovered; therefore, it is not expected that the servicing/maintenance process contributed to the reported issue.The root cause cannot be determined as there was no information available to the circumstances leading to the malfunctioning cable.Complaints are monitored through monthly complaint review (reference qi09-03) to trend the issues and discuss them during the monthly capa feeder process.Any spike or unfavorable trend will be reviewed for further action per qi09-03.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.H3 other text : robotic unit remains on site.

• Brand Name: ROSA KNEE PLATFORM US PL B
• 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: 18041575
• MDR Text Key: 326991264
• Report Number: 0009617840-2023-00017
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 20-8020-100-01
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: NI
• Patient Sequence Number: 1