MAUDE Adverse Event Report: AESCULAP AG FULL-SIZE LID W/RETENTION PLATE SILVER; STERILIZATION CONTAINER LID

Model Number JK489

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Missing Value Reason (3192)

Event Date 02/02/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional 510(k) / procode: k792558 / (b)(4).Manufacturing site evaluation: on-going.

Event Description

Country of complaint: (b)(6).Upon opening of sterilized container for orthopedic procedure, it was noticed that the filter holder had fallen into the container; sterility could not be assured.Additional instrument set had to be obtained which resulted in delay of approximately 30 minutes with patient under anesthesia.Additional component involved: jk100 / filter retention plate - medwatch report filed on this component : 2916714-2016-00194.

Manufacturer Narrative

During surgery the container was opened and the customer realized that the filter holder has fallen into the container.So sterility was not sure.The container lid is in a used condition, several scratches are visible.The retention plates are also used, but no severe damage can be identified.The products were analyzed visually and several function test were carried out.The product does not require batch management; a review of the device quality and manufacturing history records is not possible.Based on the information available as well as a result of our investigation the root cause of the failure is most probably user related.Recreated the described error, but the retention plates, so we can exclude a production or material caused error.Most likely the retention plate was not assembled probably during the mounting.According to sop sa-de13-m-4-2-01-010 a capa is not necessary.The current failure rate is within the risk analysis and therefore acceptable.

• Brand Name: FULL-SIZE LID W/RETENTION PLATE SILVER
• Type of Device: STERILIZATION CONTAINER LID
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5493706
• MDR Text Key: 40120182
• Report Number: 2916714-2016-00155
• Device Sequence Number: 1
• Product Code: FRG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K053389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: JK489
• Device Catalogue Number: JK489
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/25/2016
• Date Manufacturer Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other