MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED GLENOSPHERE 10 DEGREES TILTED 36 MM X 25MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWD181
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgical procedure, the surgeon requested the lateralized glenoid sphere +4mm the medical device had the fixation screw blocked, preventing its correct implantation in the 25mm screwed base plate.The surgeon tried to loosen the screw several times without success.Surgeon decided to request a new glenosphere to implant it to the patient.The surgeon decided to insert the eccentric glenoid sphere +2mm.The surgery ends without serious events and the patient does not present any problem or serious repercussion.Due to this situation, the surgeon did not allow the disortho surgical assistant to charge the centered glenoid sphere hospital.
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Additional Manufacturer Narrative
Please note the corrections to d9/h3 and the h6 component code: the reported event could be confirmed (jammed safety screw in the glenoid sphere before impacting) 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 or Problem Description
It was reported that during a surgical procedure, the surgeon requested the lateralized glenoid sphere +4mm the medical device had the fixation screw blocked, preventing its correct implantation in the 25mm screwed base plate.The surgeon tried to loosen the screw several times without success.Surgeon decided to request a new glenosphere to implant it to the patient.The surgeon decided to insert the eccentric glenoid sphere +2mm.The surgery ends without serious events and the patient does not present any problem or serious repercussion.Due to this situation, the surgeon did not allow the disortho surgical assistant to charge the centered glenoid sphere hospital.

• Brand Name: AEQUALIS REVERSED GLENOSPHERE 10 DEGREES TILTED 36 MM X 25MM
• 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): 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: 15849148
• Report Number: 3000931034-2022-00377
• Device Sequence Number: 5027340
• Product Code: KWS
• UDI-Device Identifier: 03700386935831
• UDI-Public: 03700386935831
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K081059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2023

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: DWD181
• Device Catalogue Number: DWD181
• Device Lot Number: 8981AW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2022
• Supplement Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2022
• 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: Female