MAUDE Adverse Event Report: ARTHREX, INC. DEFECT GAUGE, Ø30MM GRAFT ANGLE LEG; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DEFECT GAUGE, Ø30MM GRAFT ANGLE LEG
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2023
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.The complaint is confirmed.One unpackaged ar-9673-30a serial/batch number 37621938 was received for investigation.Visual evaluation found that the device was bend.The most likely cause for the reported failure can be attributed to wear and tear.
Event or Problem Description
On 3/13/2023, it was reported by a sales representative via email that an ar-9673-30a glenoid defect gauge bent and would not go through the guide handle.No further information was provided.Additional information received on 3/14/2023: this was discovered during an rtsa procedure on (b)(6) 2023 and completed as expected, the case was not affected by the bent glenoid gauge.

• Brand Name: DEFECT GAUGE, Ø30MM GRAFT ANGLE LEG
• 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: 19133592
• Report Number: 1220246-2024-02120
• Device Sequence Number: 4720613
• Product Code: LXH
• UDI-Device Identifier: 00888867324916
• UDI-Public: 00888867324916
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2024

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: DEFECT GAUGE, Ø30MM GRAFT ANGLE LEG
• Device Catalogue Number: AR-9673-30A
• Device Lot Number: 37621938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown