MAUDE Adverse Event Report: CARTIVA, INC CARTIVA IMPLANT 10MM; PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT

Model Number CAR-10-US

Device Problem Delivered as Unsterile Product (1421)

Patient Problem Insufficient Information (4580)

Event Date 02/01/2023

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

It was reported that during the procedure the physician drilled and was ready to implant a 10mm when it was noted that the product had expired on 31-jan-2023.They checked another implant and noticed that it had the same expiration date.The surgeon had to use a size 8mm cartiva after drilling for a size 10mm cartiva.The patient had a revision surgery 10 days later.

Manufacturer Narrative

The reported event can be confirmed based on expiration dates found in dhr reviews and compared with the date of event.During the investigation, it was determined that a hub team member manually changed the expiration dates within webops which allowed for the kit to be shipped with expired product inside.According to previous cases, if the sterile barrier is not damaged prior to the use of orthopedic devices that have expired, the risk of harm is lower.The packaging (i.E., which provides sterile barriers) is typically validated for 7-8 years, so sterility concerns are tempered by this fact.Based on investigation, the root cause was attributed to a distribution-storage related issue.The failure was caused by a hub member performing tasks outside of protocol.A non-conformance investigation was initiated to address the non-compliance of procedures by the hub member.A review of the device history for the reported lot did not indicate any abnormalities.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.

Event Description

It was reported that during the procedure the physician drilled and was ready to implant a 10mm when it was noted that the product had expired on 31-jan-2023.They checked another implant and noticed that it had the same expiration date.The surgeon had to use a size 8mm cartiva after drilling for a size 10mm cartiva.The patient had a revision surgery 10 days later.

• Brand Name: CARTIVA IMPLANT 10MM
• Type of Device: PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
• Manufacturer (Section D): CARTIVA, INC; 6120 windward parkway; suite 220; alpharetta GA 30005
• Manufacturer (Section G): CARTIVA, INC; 6120 windward parkway; suite 220; alpharetta GA 30005
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16456906
• MDR Text Key: 310406933
• Report Number: 3009351194-2023-00007
• Device Sequence Number: 1
• Product Code: PNW
• UDI-Device Identifier: 00852897002038
• UDI-Public: 00852897002038
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2023
• Device Model Number: CAR-10-US
• Device Catalogue Number: CAR-10-US
• Device Lot Number: F010721001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 02/28/2023
• Supplement Dates Manufacturer Received: 05/02/2023
• Supplement Dates FDA Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 84 KG