MAUDE Adverse Event Report: ZIMMER CAS IASSIST V2 POD; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: singapore.Visual and physical evaluation of the returned product was completed as part of the complaint investigation and confirmed that the inner package was deformed, likely from heat.Additionally, the inner package was still sealed, only the outer box was opened.Device history record (dhr) was reviewed for deviations and/or anomalies with no deviations/anomalies identified.Based on the information provided, the root cause for the reported is most likely related to the manufacturing process.If any further information is received which would change or alter any conclusions or information, a supplemental medwatch will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that, upon unsealing the i-assist pods box, the inner plastic container was out of shape.It looks like it has melted.This set of pods was not used.The box was completely sealed and kept in a cool environment before it was opened up.No further information available.

• Brand Name: IASSIST V2 POD
• 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: 19533138
• Report Number: 0009617840-2024-00012
• Device Sequence Number: 7483612
• Product Code: OLO
• UDI-Device Identifier: 00887868519017
• UDI-Public: (01)00887868519017(17)260811(10)MP0001298
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K213033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/13/2024

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 Expiration Date: 08/11/2026
• Device Model Number: N/A
• Device Catalogue Number: 20-8011-501-00
• Device Lot Number: MP0001298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2023
• 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: 06/11/2024
• Initial Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown