MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED GLENOSPHERE CENTERED 36 MM X 25MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number DWD180

Device Problem Mechanical Jam (2983)

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

Event Date 11/11/2022

Event Type  malfunction  

Event Description

It was reported that the central glenosphere screw does not move.Does not tighten or loosen.A lateralized style implant was used to complete the surgery instead of the centered implant.

Manufacturer Narrative

Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.

Manufacturer Narrative

Correction h6 component code.The reported event could be confirmed since the device was returned and was found to be in condition stated in the event description.The device inspection revealed the following: the visual inspection confirmed that the safety screw was jammed in the glenoid sphere.After loosening the safety screw, the functionality of the sphere was checked, and it could correctly impact and tighten into the baseplate-gauge without issue to report.The issue described in the reported event was unable to be reproduced.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that the central glenosphere screw does not move.The safety screw was found stuck right after opening the packaging.Does not tighten or loosen.A lateralized style implant was used to complete the surgery instead of the centered implant.

• Brand Name: AEQUALIS REVERSED GLENOSPHERE CENTERED 36 MM X 25MM
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 15924742
• MDR Text Key: 305168479
• Report Number: 3000931034-2022-00380
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386935824
• UDI-Public: 03700386935824
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K081059
• 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: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DWD180
• Device Catalogue Number: DWD180
• Device Lot Number: AE6715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1