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	Insufficient Information (4580)
Date of Event	11/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/17/2023, it was reported by a sales representative via email that an ar-9512 arthrex univers revers stem/cup extraction adapter handle broke off inside of an ar-9522-135r arthrex univers revers trial cup.This was discovered during an rtsa procedure on 11/17/2023.The case was completed by using the instruments from another tray.Additional information received on 11/21/2023: when the adapter handle broke off inside the trial cup, the device was inside the patient; however, there were no loose fragments in the patient.The case was delayed two minutes while waiting for another tray to be opened use the instruments and continue the case.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Complaint is confirmed.Functional testing was not performed on the returned ar-9512 due to the damage to the tip of the device.Visual evaluation noted that the tip of the device is broken off.The most likely cause is attributed to misuse due to use error.

• 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: 18340874
• Report Number: 1220246-2023-09451
• Device Sequence Number: 20532441
• 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
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2024

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 01/26/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown