MAUDE Adverse Event Report: ARTHOSURFACE REVOMOTION REVERSE TOTAL; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number 8RG0-3600-A

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/29/2024

Event Type  malfunction  

Event Description

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report does not reflect a conclusion by anika or its employees that the report constitutes an admission that the device, anika, or its employees caused or contributed to a potential patient event documented on this report.On (b)(6) 2024 it was reported to anika that during a reverse tsa procedure on a male patient of unknown age and demographic the glenosphere insertion shaft broke off and was left inside the glenoid head.The procedure continued with a 15-minute delay in the procedure.There was no report of any defect with the instrument or packaging prior to the procedure.There was no negative patient impact reported.The current status of the patient is unknown.Additional information was requested.

Manufacturer Narrative

The case is still under investigation.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.

Manufacturer Narrative

The case is still under investigation.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.The reported event is not confirmed.It was reported to anika that the glenoid tip broke off flush inside the glenoid head and was left in the glenoid head.The procedure continued with a ~15-minute delay.There was no report of any defects with the device prior to use or the packaging.A review of the batch record was performed.The device was manufactured to specifications and applicable procedures.A retrospective review of all nonconformances was performed.There was no nonconformances related to the reported event.The manufacturer does not maintain retention inventory of this product.There was no inspection of retention inventory performed.The case will be monitored for trending and analysis.A supplemental report will be submitted upon receipt of new and relevant information.

Event Description

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report does not reflect a conclusion by anika or its employees that the report constitutes an admission that the device, anika, or its employees caused or contributed to a potential patient event documented on this report.On 06march2024 it was reported to anika that during a reverse tsa procedure on a male patient of unknown age and demographic the glenosphere insertion shaft broke off and was left inside the glenoid head.The procedure continued with a ~15-minute delay in the procedure.There was no report of any defect with the instrument or packaging prior to the procedure.There was no negative patient impact reported.The current status of the patient is unknown.Additional information was requested.

• Brand Name: REVOMOTION REVERSE TOTAL
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHOSURFACE; 28 forge parkway; franklin MA 02038
• Manufacturer (Section G): PRIMO MEDICAL GROUP; 75 mill street; stoughton MA 02072
• Manufacturer Contact: keith kelly ; 28 forge parkway; franklin, MA 02038
• MDR Report Key: 18975097
• MDR Text Key: 338992596
• Report Number: 3004154314-2024-00001
• 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: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

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 Catalogue Number: 8RG0-3600-A
• Device Lot Number: 75CC8568
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/25/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1