MAUDE Adverse Event Report: FX SOLUTIONS HUMERIS; REVERSE SHOULDER PROSTHESIS

Catalog Number 108-4520

Device Problem Crack (1135)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/24/2020

Event Type  malfunction  

Event Description

As surgeon was tightening down baseplate locking screw size 20 during reverse surgery on (b)(6) 2020, the screw head formed crack down the middle.As they attempted to remove screw, crack worsened and surgeon was unable to secure a screwdriver into the screw.Surgeon made decision to leave screw in and took extra precautions to prevent infection.

• Brand Name: HUMERIS
• Type of Device: REVERSE SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 9837077
• MDR Text Key: 189626915
• Report Number: 3014128390-2020-00011
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/16/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2024
• Device Catalogue Number: 108-4520
• Device Lot Number: N1935
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/16/2020
• Distributor Facility Aware Date: 02/24/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/27/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR