MAUDE Adverse Event Report: ARTHREX, INC. AUGMENTED VAULTLOCK BROACH; ORTHOPEDIC MANUAL SURG INSTR

Model Number	AUGMENTED VAULTLOCK BROACH
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A sales representative reported via (b)(4) on 07/03/2024 that an ar-9233ag augmented vaultlock broach had an issue.The mallet broke off when the surgeon malleated it.This was discovered before use during a procedure on (b)(6) 2024, with no reported patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged ar-9233ag serial/batch number (b)(6) was received for investigation.Upon visual evaluation, it was noted that the strike plate is likely missing because of the break.Signs of wear and tear was noted.Functional testing was not performed as the device was broken.The most likely cause of the reported failure is wear and damage due to repeated use and/or reprocessing.

• Brand Name: AUGMENTED VAULTLOCK BROACH
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 19820235
• Report Number: 1220246-2024-06894
• Device Sequence Number: 21000471
• Product Code: LXH
• UDI-Device Identifier: 00888867350366
• UDI-Public: 00888867350366
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/26/2024

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: AUGMENTED VAULTLOCK BROACH
• Device Catalogue Number: AR-9233AG
• Device Lot Number: 052043
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2021
• 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