MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED GLENOSPHERE ECCENTRIC 36 MM X 25MM; PROSTHESIS SHOULDER JOINT METAL

Model Number	GLENOSPHERE ECCENTRIC 36 MM X 25MM
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
We could noticed that the safety screw of the glenosphere is blocked, like welded as soon as the implant was unpacked.It was impossible for me to unblock it, as well as the surgeon who is very familiar with our implants.Procedure completed with a second glenosphere.Surgical delay : 20min.
Event or Problem Description
We could noticed that the safety screw of the glenosphere is blocked, like welded as soon as the implant was unpacked.It was impossible for me to unblock it, as well as the surgeon who is very familiar with our implants.Procedure completed with a second glenosphere.Surgical delay : 20min.
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned and found to be in the condition stated in the event description (jammed safety screw before impacting).The device inspection revealed the following: the visual inspection confirmed that the safety screw was jammed inside 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 complaint was unable to be reproduced.Due to the nature of the reported issue, a dimensional inspection of this device was not considered as relevant.However, during manufacturing, functionality test and dimensional inspection were done according to specifications.During the inspection, all devices met the specifications.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.To date, no recurrence link could be identified as part of the complaints investigation performed for jammed glenoid sphere safety screw issue (reference, batch number, manufacturing location, event country).To date, the additional tests initiated did not allow to identify the exact root cause at the origin of the issue.An inspection of the screw mobility was included as an additional control in the clean room before the packaging of the device.The glenoid sphere involved in the current complaint was manufactured before the implementation of this control.A deeper investigation is still in progress and this case will be reassessed if this is deemed necessary.

• Brand Name: AEQUALIS REVERSED GLENOSPHERE ECCENTRIC 36 MM X 25MM
• Common Device Name: PROSTHESIS SHOULDER JOINT METAL
• 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: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 12200642
• Report Number: 3000931034-2021-00293
• Device Sequence Number: 13826362
• Product Code: KWS
• UDI-Device Identifier: 03700386935848
• UDI-Public: 03700386935848
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K081059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2021

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 Expiration Date: 05/20/2025
• Device Model Number: GLENOSPHERE ECCENTRIC 36 MM X 25MM
• Device Catalogue Number: DWD182
• Device Lot Number: 4697AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 12/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown