MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVS STEM/CUP EXTRACT ADPTR HNDL; MANUAL INSTR, GENERAL SURGICAL

Model Number	UNIVERS REVS STEM/CUP EXTRACT ADPTR HNDL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint is confirmed.One unpackaged ar-9512 serial/batch number (b)(6) was received for investigation.Visual evaluation noted that the threads are damaged.It was noted that the laser marks are fading, discoloration spots, and scratches in the shaft.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.

• Brand Name: UNIVERS REVS STEM/CUP EXTRACT ADPTR HNDL
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 17273165
• Report Number: 1220246-2023-07086
• Device Sequence Number: 5281429
• Product Code: MDM
• UDI-Device Identifier: 00888867061866
• UDI-Public: 00888867061866
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: UNIVERS REVS STEM/CUP EXTRACT ADPTR HNDL
• Device Catalogue Number: AR-9512
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown