MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS MCP SZ. 10 PROXIMAL WW

Catalog Number MCP-100-10P-WW

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A distributor reported that the customer was set to have a procedure on (b)(6) 2020 and when opening the mcp box they found the box empty.The only material in the box was the instructions for use and the patient record labels.After discussing the issue, the medical staff opted to use a bigger size.The event led to 30 minutes surgical delay.

Manufacturer Narrative

Updated fields: udi - (b)(4).A review of the lot records was conducted.There were no indications of problems that could have caused or contributed to the complaint.According to the rework records, the labels on both the exterior and interior of the packages were replaced.The packaging has not yet been returned to integra for evaluation, but photographs were provided by the customer.The photographs show the opened and, apparently, empty box.The label information is visible, confirming that the package was expected to contain an implant from product lot 173989tm.The package label shows all accurate information.The complaint alleges that the box was found empty except for the instructions for use (ifu) and the patient record labels, though these documents were not shown in the photographs.The failure was confirmed.A definitive root cause cannot be determined.According to warehouse supervisor, it is possible that the box could have been sealed empty as the implant is lightweight and an empty box might not have been detected.

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.Product was received for evaluation: dhr - there were no indications of problems that could have caused or contributed to the complaint.Failure analysis - the box was found to be empty.The failure was confirmed.Root cause - examination of the returned packaging confirmed that the most likely potential causes for the empty box include that the box was sealed empty during the original manufacturing in 2017.

• Brand Name: MCP SZ. 10 PROXIMAL WW
• Type of Device: MCP
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX 78754
• MDR Report Key: 10949364
• MDR Text Key: 247629726
• Report Number: 1651501-2020-00021
• Device Sequence Number: 1
• Product Code: NEG
• Combination Product (y/n): N
• PMA/PMN Number: P000057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: MCP-100-10P-WW
• Device Lot Number: 173989TM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Date Manufacturer Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1