MAUDE Adverse Event Report: ZIMMER CAS IASSIST KNEE 2-POD KIT; ORTHOPEDIC STEROTAXIC 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	05/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the iassist pods were unable to connect to the tablet.Since there was no backup iassist pods, the surgery was cancelled and rescheduled for the following week.The patient was already under anesthesia at this time.The following week, the surgery was completed without any issues.No further information is available.
Additional Manufacturer Narrative
(b)(4).The device was not returned and the software application log files were not available for evaluation.A device history record review was conducted and no deviations or anomalies were identified that could have contributed to the reported event.As the reported event cannot be confirmed, a definitive root cause could not 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.H3 other text : discarded.

• Brand Name: IASSIST KNEE 2-POD KIT
• Common Device Name: ORTHOPEDIC STEROTAXIC 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: 17622511
• Report Number: 0009617840-2023-00015
• Device Sequence Number: 7318579
• Product Code: OLO
• UDI-Device Identifier: 00889024305250
• UDI-Public: (01)00889024305250(17)250210(10)NMK000430B
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K213033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/24/2023

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 Expiration Date: 02/10/2025
• Device Model Number: N/A
• Device Catalogue Number: 20-8011-002-00
• Device Lot Number: NMK000430 B
• 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: 05/18/2023
• Initial Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male