MAUDE Adverse Event Report: TORNIER S.A.S. CEMENTED AEQUALIS INSTRUMENTATION SET; ORTHOPEDIC TRAY

Catalog Number YKAD22

Device Problem Component Missing (2306)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 09/16/2019

Event Type  Injury  

Manufacturer Narrative

This is the initial report submitted regarding this surgical event and medical device.

Event Description

Upon opening up instruments in theatre it was discovered that the wrong trays had been dispatched to the hospital.The patient was already asleep and there were no sterile sets of the correct instruments in the area.Operation had to be cancelled and patient woken up.Patient was anesthesised and so had to be woken up without surgery having happened.

Manufacturer Narrative

This is the final report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.This submission does not constitute a determination or admission that a device has malfunction or is related to a death or injury.

• Brand Name: CEMENTED AEQUALIS INSTRUMENTATION SET
• Type of Device: ORTHOPEDIC TRAY
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• MDR Report Key: 9193458
• MDR Text Key: 168624051
• Report Number: 3000931034-2019-00139
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: YKAD22
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other