MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS VAULTLOCK GRAFT COMPRESSION TOOL; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	UNIVERS VAULTLOCK GRAFT COMPRESSION TOOL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 03/02/2023, it was reported by a sales representative via sems that an ar-9236gt graft compression tool broke.This occurred during a case, with no patient effect reported.No additional information was provided.
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
Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause of this failure is attributed to wear and tear damage incurred over repeated usage.Manufactured date 2016.

• Brand Name: UNIVERS VAULTLOCK GRAFT COMPRESSION TOOL
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• 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: 16597183
• Report Number: 1220246-2023-06472
• Device Sequence Number: 11891767
• Product Code: MDM
• UDI-Device Identifier: 00888867254732
• UDI-Public: 00888867254732
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 09/05/2024

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 VAULTLOCK GRAFT COMPRESSION TOOL
• Device Catalogue Number: AR-9236GT
• Device Lot Number: 45551608
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2023
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown