MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED GLENOSPHERE CENTERED 36 MM X 29MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWD190
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
The grub screw of the glenosphere could not be screwed; it was tight or jammed and therefore could not be screwed/secured into the base plate.As an alternative, the eccentric glenosphere was used.
Event or Problem Description
The grub screw of the glenosphere could not be screwed; it was tight or jammed and therefore could not be screwed/secured into the base plate.As an alternative, the eccentric glenosphere was used.
Additional Manufacturer Narrative
The reported event could be confirmed (jammed safety screw in the glenoid sphere when opening the packaging) 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.

• Brand Name: AEQUALIS REVERSED GLENOSPHERE CENTERED 36 MM X 29MM
• Common Device Name: 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): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16542253
• Report Number: 3000931034-2023-00065
• Device Sequence Number: 17772380
• Product Code: KWS
• UDI-Device Identifier: 03700386935886
• UDI-Public: 03700386935886
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K081059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DWD190
• Device Catalogue Number: DWD190
• Device Lot Number: AE7127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2023
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown