MAUDE Adverse Event Report: TORNIER S.A.S. AEQ REV II GLENOID SPHERE DIA 39 X 25 CENTERED BASEPLATE; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number	DWH904
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2023
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
It was reported that during a procedure it was impossible to screw the glenosphere on the baseplate.The screw turned freely.The physician changed the glenosphere twice but they both had the same issue.The procedure could be completed correctly by changing the glenosphere style.
Event or Problem Description
It was reported that during a procedure it was impossible to screw the glenosphere on the baseplate.The screw turned freely.The physician changed the glenosphere twice but they both had the same issue.The procedure could be completed correctly by changing the glenosphere style.
Additional Manufacturer Narrative
The reported event could not be confirmed since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: -visually, the security screw was received loose in the glenoid sphere.Probably due to several attempts to loosen the central safety screw during the surgery, the hexagonal footprint of the safety screw was found damaged and the polished surface of the sphere was found scratched with several large and deep scratches.-functionally, the sphere could correctly impact and tighten into a ø25mm baseplate with no issue to report.The issue described in the reported event was unable to be reproduced.The sphere was functional.A review of the device history for the reported lot did not indicate any abnormalities.During manufacturing, functionality test and dimensional inspection were done according to specifications.All devices met the specifications.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.The absence of the peripheral groove around the baseplate, the remained soft tissues between the baseplate and the glenoid sphere or inside the baseplate threading hole are the most probably causes for the reported event.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by inadequate use of the hcp (a functional test showed that the device was functional).If any additional information is provided, the case will be reassessed.

• Brand Name: AEQ REV II GLENOID SPHERE DIA 39 X 25 CENTERED BASEPLATE
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: 16534649
• Report Number: 3000931034-2023-00063
• Device Sequence Number: 6388762
• Product Code: HSD
• UDI-Device Identifier: 03700386955075
• UDI-Public: 03700386955075
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2023

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: DWH904
• Device Catalogue Number: DWH904
• Device Lot Number: 3247AX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/15/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2021
• 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