MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS HUMERAL CUP REAMER -S/36; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	UNIVERS REVERS HUMERAL CUP REAMER -S/36
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection was unremarkable and found no issue with the device.Complaint was not confirmed.
Event or Problem Description
On 08/12/2022, it was reported by a sales representative via sems that a ar-9508-36 humeral cup reamer, and a ar-9510rg-l reamer guide got stuck.This occurred on (b)(6) 2022 during a reverse total shoulder arthroplasty when reaming the humeral head the revers apex stem broach was in, the l centering peg was in the broach, and when it was time to ream the reamer kept getting caught in the peg which wouldn't allow it to ream.The surgeon ended up removing the centering pin and reamed freehand.The case was completed, with no patient effect reported.Additional information requested.Additional information provided on 08/24/2022 that the inside of the reamer looks shredded and has nicks from the centering pin.Debris was produced and removed.

• Brand Name: UNIVERS REVERS HUMERAL CUP REAMER -S/36
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: vik bajnath ; 8009337001
• MDR Report Key: 15940551
• Report Number: 1220246-2022-05910
• Device Sequence Number: 6210175
• Product Code: LXH
• UDI-Device Identifier: 00888867061545
• UDI-Public: 00888867061545
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 12/08/2022

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 REVERS HUMERAL CUP REAMER -S/36
• Device Catalogue Number: AR-9508-36
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 12/08/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown