MAUDE Adverse Event Report: ARTHREX, INC. DRILL GUIDE, UNIVERS VAULTLOCK GLEN, MD; MANUAL INSTR, GENERAL SURGICAL

Model Number	DRILL GUIDE, UNIVERS VAULTLOCK GLEN, MD
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint is confirmed.Upon visual evaluation, it was noted that one of the holes has damaged on the thread area and the part of the threaded tip at the distal end of the drill guide handle that broke off is inside the drill guide.The device has corrosion marks on it.The most likely cause for the reported failure can be attributed to wear and tear.
Event or Problem Description
On 08/18/2022, it was reported by a sales representative via sems that an ar-9236-02pp univers vaultlock¿ glenoid trial, medium, an ar-9215-1-02 glenoid drill guide handle, long and an ar-9231-02pp drill guide, univers vaultlock¿ glenoid, medium had an issue during a total shoulder arthroplasty procedure on (b)(6) 2022.It was a tough anatomic shoulder arthroplasty case with tight exposure.When removing the medium vaultlock drill guide, the threaded tip of the drill guide handle broke off inside the drill guide, rendering both instruments defective.Later when removing the medium vaultlock trial, the central peg broke off.The piece broke off inside the patient and was retrieved from the patient.The case was completed successfully.The ar-9236-02pp was not available for return as it was disposed of by the hospital staff.This was discovered during use with no impact to the patient.

• Brand Name: DRILL GUIDE, UNIVERS VAULTLOCK GLEN, MD
• 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: jared engle ; 8009337001
• MDR Report Key: 19469661
• Report Number: 1220246-2024-04953
• Device Sequence Number: 12606535
• Product Code: MDM
• UDI-Device Identifier: 00888867239043
• UDI-Public: 00888867239043
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2024

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: DRILL GUIDE, UNIVERS VAULTLOCK GLEN, MD
• Device Catalogue Number: AR-9231-02PP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 06/05/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown