MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED GLENOID SPHERE; SHOULDER JOINT METAL PROSTHESIS

Model Number	ECC. 2MM DIAM. 36MM FOR 25MM BASEPLATE
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Mechanical Jam (2983)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the initial report submitted regarding this surgical event, and medical device.
Event or Problem Description
During the surgical procedure when the doctor requested the 10° tilted sphere (reference (b)(4), serial number (b)(4)), the medical device had the screw blocked, preventing its proper implantation to the threaded post baseplate (reference (b)(4), serial number (b)(4)).The surgeon tried to release the screw several times without success.The doctor sanchez decides apply for the eccentric glenoid sphere (reference (b)(4), serial number (b)(4)) to implant it the patient, but had the same problem, the medical device had the screw blocked.The surgeon decides to insert the centered glenoid sphere, (reference (b)(4), serial number (b)(4)).The surgery ends without serious events, and the patient does not have any problem or serious impact.This event implied that the anesthesia time was extend for a period of 40 minutes.
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.This submission does not constitute a determination or admission that a device has malfunction or is related to a death or injury.

• Brand Name: AEQUALIS REVERSED GLENOID SPHERE
• Common Device Name: SHOULDER JOINT METAL PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• MDR Report Key: 10612219
• Report Number: 3000931034-2020-00130
• Device Sequence Number: 3830429
• Product Code: KWS
• UDI-Device Identifier: 03700386935848
• UDI-Public: 03700386935848
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• PMA/510(K) Number: K081059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/24/2025
• Device Model Number: ECC. 2MM DIAM. 36MM FOR 25MM BASEPLATE
• Device Catalogue Number: DWD182
• Device Lot Number: 3004AV
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/04/2020
• Supplement Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other