MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS REDUCTION HELPER; MANUAL INSTR, GENERAL SURGICAL

Model Number	UNIVERS REVERS REDUCTION HELPER
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On 11/2/2023, it was reported by a sales representative via (b)(4) that an ar-9545 univers revers reduction helper had a piece snap off.The case was completed using a different product.This was discovered during an unspecified procedure, with no reported patient harm.Additional information received on 11/7/2023: the ar-9545 univers revers reduction helper had a piece snap off inside the patient.All fragments were retrieved.There was no reported delay in the case.The case continued and the ar-9545 univers revers reduction helper was no longer needed to complete the case.This was discovered during a rtsa procedure on 11/1/2023.
Additional Manufacturer Narrative
Additional information: h6.Complaint is confirmed.Functional testing was not performed due to the damage to the device.Visual inspection noted the device has a broken tip.The most likely cause for the reported failure can be attributed to use error due to excessive user-applied mechanical forces.Refer to the investigation photo.

• Brand Name: UNIVERS REVERS REDUCTION HELPER
• 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: 18229177
• Report Number: 1220246-2023-08982
• Device Sequence Number: 15008198
• Product Code: MDM
• UDI-Device Identifier: 00888867141636
• UDI-Public: 00888867141636
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 02/15/2024

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 REVERS REDUCTION HELPER
• Device Catalogue Number: AR-9545
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 02/15/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown