MAUDE Adverse Event Report: ARTHREX, INC. AUGMENTED VAULTLOCK DRILL GUIDE, M 25L; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	AUGMENTED VAULTLOCK DRILL GUIDE, M 25L
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/11/2022, it was reported by a sales representative via sems that an ar-9231-02ag-25l univers vaultlock augmented glenoid drill guide and an ar-9215-1-03 universal quick connect handle had an issue.During an anatomic total shoulder replacement procedure on (b)(6) 2022, the surgeon snapped off the 25 degree medium left augmented vautlock drill guide intraoperatively.No piece broke off inside the patient.They placed the drill guide by hand-holding orientation with a coker while the superior drill bit was driven to a positive stop.The case was completed successfully.This was discovered during use with no impact to the patient.Additional information has been requested.On 10/11/2022, the sales representative stated the following information via phone: the instruments were within the incision inside the patient when they broke, but all fragments were retrieved fully.The case was completed successfully with no impact to the patient.Both complaint devices are available for return.
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
The device was not received for evaluation and no photo was provided; complaint not confirmed.The most likely probable cause of the event is attributed to use error due to excessive force on the guide.

• Brand Name: AUGMENTED VAULTLOCK DRILL GUIDE, M 25L
• 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: 15710034
• Report Number: 1220246-2022-05692
• Device Sequence Number: 6508724
• Product Code: LXH
• UDI-Device Identifier: 00888867350274
• UDI-Public: 00888867350274
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 10/04/2023

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 DRILL GUIDE, M 25L
• Device Catalogue Number: AR-9231-02AG-25L
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2022
• Supplement Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 10/04/2023
• 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