MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED GLENOSPHERE ECCENTRIC 42MM X 29MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	DWD195
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It is reported that it was impossible to screw the glenoid base when impacting glenosphere.The glenosphere has been replaced by one less suited to the patient's case.It may increased risk of infection and loss of postoperative recovery".
Event or Problem Description
It is reported that it was impossible to screw the glenoid base when impacting glenosphere.The glenosphere has been replaced by one less suited to the patient's case.It may increased risk of infection and loss of postoperative recovery.".
Additional Manufacturer Narrative
Correction - please refer h6 - health code.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 central safety screw was received loose in the glenoid sphere.Probably due to attempts to place/screw the glenosphere in the baseplate during the surgery, the polished surface of the sphere was found slightly scratched.Functionally, the sphere could correctly impact and tighten into a 029mm 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.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.The labeling states that: prior to positioning of the definitive glenoid sphere it is important to remove any soft tissue between the baseplate and the glenoid sphere.It is mandatory that the glenoid sphere is screwed manually.Particular cautions for the assembling of the glenoid sphere onto the glenoid baseplate - first place the sphere in front of the baseplate, without screwing the central screw - then impact the sphere onto the baseplate with the glenoid sphere impactor and finally secure the assembly by screwing the sphere central screw into the baseplate clockwise.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 investigation will be reassessed.

• Brand Name: AEQUALIS REVERSED GLENOSPHERE ECCENTRIC 42MM 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): 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: 20064618
• Report Number: 3000931034-2024-00477
• Device Sequence Number: 18074654
• Product Code: KWS
• UDI-Device Identifier: 03700386935930
• UDI-Public: (01)03700386935930(11)220921(17)270921(21)5891AX001
• 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: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DWD195
• Device Lot Number: 5891AX
• 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: 07/30/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown