MAUDE Adverse Event Report: AESCULAP AG AESCULAP SURGICAL INSTRUMENTS; GENERAL SURGICAL INSTRUMENTS

Model Number JK489

Device Problems Shipping Damage or Problem (1570); Manufacturing, Packaging or Shipping Problem (2975); Material Deformation (2976); Material Integrity Problem (2978)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 03/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).If additional information is received a follow up report will be submitted.

Event Description

It was reported the lids were warped causing sterility concerns.The reporter indicated that upon preparation of the or for an enduro hinge total knee revision (tkr) case, it was discovered that 4 out of the 10 sterile containers for the enduro instrument sets had lids that were warped (likely from shipping).The containers did not seem to be holding a tight vacuum seal around filter.Due to sterility concerns, the case was cancelled and rescheduled for the follow day (b)(6) 2019.The patient was not yet under anesthesia, however, due to the cancellation of the procedure, the patient required an extra day/night in the hospital.The surgery did occur the following day as planned.No patient information has been provided.Additional information has been requested, however, not yet received.

Manufacturer Narrative

Investigation results: the device was returned to the manufacturer on 01apr2019.The root cause cannot be identified because the location of the lids cannot be identified.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.Due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• Brand Name: AESCULAP SURGICAL INSTRUMENTS
• Type of Device: GENERAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8545445
• MDR Text Key: 143036218
• Report Number: 2916714-2019-00013
• Device Sequence Number: 1
• Product Code: FRG
• Combination Product (y/n): N
• PMA/PMN Number: K053389
• 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: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JK489
• Device Catalogue Number: JK489
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/28/2019
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: JN442 CONTAINER
• Patient Outcome(s): Hospitalization