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	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-9512, extraction adapter handle, batch 37622422, was received for investigation.Visual inspection noted: no issues with the device's exterior.Threads were examined under the microvu to assess for damage; no issues were observed.Functional testing confirmed the device threaded as intended.Complaint allegation is not confirmed.Refer to the attached investigation photos.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 10/10/2025, it was reported by a sales representative via (b)(4).That an ar-9512 extractor handle, the bolt that attaches to the gig the bolt and jig cross threaded together and got stuck, broke the screwdriver because it was tight.Noticed during a case and swapped with no patient effect.

• 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: 23439578
• Report Number: 1220246-2025-04941
• Device Sequence Number: 18299115
• Product Code: MDM
• UDI-Device Identifier: 00888867061866
• UDI-Public: 00888867061866
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 12/29/2025

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: 10/10/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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