MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS SUTURE CUP, 42 (+2 RIGHT); SHOULDR PROSTH HEMI- HUM UNCEM

Model Number UNIVERS REVERS SUTURE CUP, 42 (+2 RIGHT)

Device Problem Break (1069)

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

Event Date 06/15/2023

Event Type  Injury  

Event Description

On 06/16/2023, it was reported by a sales representative via sems that an ar-9512 stem / cup extraction adapter handle was stripped, and an ar-1999hh ratcheting handle broke.This occurred during an reverse total shoulder arthroplasty revision case on (b)(6) 2023, while taking the suture-cup out of the ar-9512 it stripped and could not twist into the suture-cup.While taking the baseplate out the ar-1999hh broke and did not ratchet appropriately.Another of the same part was used to continue.The case carried on and was completed successfully.There was no additional information provided, additional information has been requested.Additional information was provided on 06/26/2023, it was reported that on(b)(6) 2021 the patient underwent a reverse total shoulder arthroplasty procedure in which ar-9502f-42rcpc suture cup, an ar-9503l-03c humeral insert, and an ar-9550-09 univers revers¿ spacer were implanted.On (b)(6) 2023 the patient underwent a reverse total shoulder arthroplasty revision procedure where the ar-9502f-39rcpc, and ar-9503m-06 were explanted.The case was completed using other parts.

• Brand Name: UNIVERS REVERS SUTURE CUP, 42 (+2 RIGHT)
• Type of Device: SHOULDR PROSTH HEMI- HUM UNCEM
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: emily shafer ; 8009337001
• MDR Report Key: 17273076
• MDR Text Key: 318577169
• Report Number: 1220246-2023-07084
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161782
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNIVERS REVERS SUTURE CUP, 42 (+2 RIGHT)
• Device Catalogue Number: AR-9502F-42RCPC
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/16/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other