MAUDE Adverse Event Report: AEQUALIS PERFORM REVERSED; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	MWJ111
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned at time of this report.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
Allegedly, the surgeon identified through x-ray that there was something in the patient's bone resembling a tip of a drill bit.Upon a search in sterile processing the drill was located and the drill is missing the top portion.
Event or Problem Description
Allegedly, the surgeon identified through x-ray that there was something in the patient's bone resembling a tip of a drill bit.Upon a search in sterile processing the drill was located and the drill is missing the top portion.
Additional Manufacturer Narrative
The reported event could be confirmed.The device was returned and found to be in the condition stated in the event description.Based on investigation, the root cause was attributed to a design related issue.The failure was caused by design error.A review of the device history for the reported lots 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.If any further information is provided, the complaint report will be updated.

• Brand Name: AEQUALIS PERFORM REVERSED
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• MDR Report Key: 11803706
• Report Number: 3004983210-2021-00042
• Device Sequence Number: 3909170
• Product Code: PHX
• UDI-Device Identifier: 00846832062348
• UDI-Public: 00846832062348
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2021

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 Catalogue Number: MWJ111
• Device Lot Number: BA07171128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 10/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1