MAUDE Adverse Event Report: AESCULAP AG ENDURO INSTRUMENT SET V2; KNEE ENDOPROSTHETICS

Model Number ST1025

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with enduro instrument set v2 filter cover.During preparation for a procedure, the filter lid was not sealed correctly.This was found upon opening the set in the operating room.It was noted that the sterile containers had appeared "beat up" upon arrival.The surgery was delayed nearly 2 hours while having the trays reprocessed/resterilized.Additional information was requested.There was no intervention required.The adverse event/malfunction is filed under (b)(4).

Manufacturer Narrative

Investigation results: the set st1025 was returned to set world on 12/17/2019 and qc inspected on 12/20/2019.Based on our set inspection plan, all of the lids and retention plates passed inspection.Our investigation determined that there was no issue with the lids or retention plates, this was most likely an operator issue.It is possible that they did not get the retention plates seated completely.It was most likely human error in sterile processing.

• Brand Name: ENDURO INSTRUMENT SET V2
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9559702
• MDR Text Key: 179478818
• Report Number: 9610612-2019-00890
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ST1025
• Device Catalogue Number: ST1025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1