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	05/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 5/30/2024 it was reported by a sales representative via (b)(4) that an ar-9512 arthrex univers revers stem/cup extraction adapter handle tip broke off during use.A photo is attached.This was discovered during a procedure on (b)(6) 2024, with no reported patient harm.Additional information was received on 6/5/2024: the ar-9512 arthrex univers revers stem/cup extraction adapter handle tip broke off during extraction of the suture cup while inside the patient.All fragments were retrieved.There was no case delay reported.This was discovered during a revision reverse shoulder arthroplasty procedure on (b)(6) 2024.The case was completed by opening another tray with the same device.No adverse effects on the patient reported due to the issue.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged, ar-9512, stem/cup extraction adapter handle, serial/batch number (b)(6), was received for investigation.Visual inspection, under a magnifier, noted that the threads of the device are nicked and damaged.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to misuse due to excessive user-applied mechanical forces.

• 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: jared engle ; 8009337001
• MDR Report Key: 19622243
• Report Number: 1220246-2024-06444
• Device Sequence Number: 8486598
• Product Code: MDM
• UDI-Device Identifier: 00888867061866
• UDI-Public: 00888867061866
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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
• Operator of Device: Health Professional
• Device Model Number: UNIVERS REVS STEM/CUP EXTRACT ADPTR HNDL
• Device Catalogue Number: AR-9512
• Device Lot Number: 250130400
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown