MAUDE Adverse Event Report: AESCULAP AG FILTER RETENTION PLATE; STERILIZATION CONTAINERS

Model Number JK100

Device Problem Material Erosion (1214)

Patient Problem No Code Available (3191)

Event Date 11/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 a component of the sterile container.Shavings from the filter retention plate were found in the bottom of the tray.The customer is placing different orthopedic sets into the instrument container and on top of the retention plate.The retention plate is perforated and full-size.The customer then transports the container and set to the hospital and feels that the tray is shifting within.As a result of the shifting, it is felt that the tray is shaving small amounts of plastic off the retention plate.Little black particles have being found in the bottom of the tray.This incident caused one surgical procedure to be cancelled (to be confirmed).Further details have been requested but not yet provided.

Manufacturer Narrative

Investigation: no product is at hand.Conclusion and root cause: no product available and therefore it is hardly possible to determine an exact conclusion and root cause.We assume that the cause of the failure is not product related.There is the possibility that the root cause of the problem is most probably usage related.Rationale: unfortunately due to a lack of data and without the product we can not determine the exact cause.According to the quality standard, a material defect and production error can be excluded.There is the possibility that the filter retention plates jk100 have been damaged by improper handling.The shaving off could have been caused by sharp instruments or a usage of incorrect trays.If they have used perforated bottoms, the filter could have been shaved due to incorrect trays.If further investigations are required, the product should be provided for examination.No capa is necessary.Information received 1/24/2019.

Event Description

The case was cancelled and the patient was not in the room.The material that is coming off of the black retention plate is microscopic, but still visable to the naked eye.The retention plates were disposed of.

• Brand Name: FILTER RETENTION PLATE
• Type of Device: STERILIZATION CONTAINERS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8171659
• MDR Text Key: 130621918
• Report Number: 9610612-2018-00598
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• PMA/PMN Number: K792558
• 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: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JK100
• Device Catalogue Number: JK100
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/14/2019
• Date Manufacturer Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FILTER PAPER; INSTRUMENT TRAY