MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED II GLENOID BOX; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Catalog Number YKAD97

Device Problems Problem with Sterilization (1596); Scratched Material (3020)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2023

Event Type  malfunction  

Event Description

As reported: "the base of the above tray has apparently been cutting the kinguard after sterilization." update: it was noticed by the theatre nursing staff while opening trays prior to surgery who requested the tray be inspected and repaired.The procedure was completed, there was no delay and no adverse consequences - the instruments were simply re-sterilized in a different tray.

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Manufacturer Narrative

Please note correction to d9/h3.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided than provided pictures.However, pictures did not provide conclusive confirmation of the issue noted in this complaint.Affected device was not returned for investigation.But provided pictures revealed that brackets, located at the base or/and tray of the box, are worn: deformed, scratched, with cutting edges.No pictures was provided with the sterile wrap ("kinguard") cut after the sterilization.Based on reported information, this box was used most likely for a long time (item was in service for "a number of years", was used approximatively "likely >100", was reprocessed (sterilized) "likely >200", was a part of a loaner kit and was sent out for "likely >100").A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.Also, kits do not have dhr¿s.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the exact root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

As reported: "the base of the above tray has apparently been cutting the kinguard after sterilization." update: it was noticed by the theatre nursing staff while opening trays prior to surgery who requested the tray be inspected and repaired.The procedure was completed, there was no delay and no adverse consequences - the instruments were simply re-sterilized in a different tray.

• Brand Name: AEQUALIS REVERSED II GLENOID BOX
• Type of Device: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18314858
• MDR Text Key: 330874391
• Report Number: 3000931034-2023-00458
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: YKAD97
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1