MAUDE Adverse Event Report: ZIMMER CAS IASSIST KNEE SYSTEM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number N/A

Device Problems Use of Device Problem (1670); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/21/2015

Event Type  Injury  

Manufacturer Narrative

Evaluation of the returned devices did not find any functional problem, and analysis of the log files indicated that the intra-op calibration was not performed as required in the instructions for use.Based on the available evidence, the surgery could not be completed because the intra-op calibration of the pods was never performed.The logs showed that warnings were displayed to the user informing that the intra-op calibration tray was not oriented as required as per the 2-pod surgical technique.The user is notified with multiple messages about the calibration process error.The warnings are displayed as an error message on system controller with a picture of the calibration tray orientation, an audio cue which specifies that the system is currently in error, and all of the pods have their status led lit red.

Event Description

It was reported during an initial knee arthroplasty, 2 pods stopped working immediately after turning them on.Due to the issue with the pods, it was reported there was a 30 minute delay of the surgical procedure.

• Brand Name: IASSIST KNEE SYSTEM
• 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: isabelle laframboise ; 75 queen street; suite 3300; montreal, quebec H3C 2-N6 ; CA H3C 2N6 ; 51486
• MDR Report Key: 5885931
• MDR Text Key: 52421352
• Report Number: 0009617840-2016-00034
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: PK141601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 20-8011-002-00
• Device Lot Number: 56005
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other