MAUDE Adverse Event Report: AEQUALIS REVERSED GLENOID SPHERE; SHOULDER JOINT METAL PROSTHESIS

Model Number	25MM 10° TILTED 36MM
Medical Device Problem Codes	Material Fragmentation (1261); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/09/2019
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
Tip of the screwdriver gripped in the glenosphere.Delay has been 30 minutes.In one of the glenospheres the tip of the screwdriver remained.It broke while trying to unscrew it on the table, we had a second screwdriver tip in the instruments.Inadequate size implant to complete the case.Patient ended with 42 head size.
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
• MDR Report Key: 9558293
• Report Number: 3000931034-2019-00188
• Device Sequence Number: 2224248
• Product Code: KWS
• UDI-Device Identifier: 03700386935831
• UDI-Public: 03700386935831
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 12/09/2019

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: 04/05/2023
• Device Model Number: 25MM 10° TILTED 36MM
• Device Catalogue Number: DWD181
• Device Lot Number: 3774AT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 04/14/2020
• 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