MAUDE Adverse Event Report: ARTHREX, INC. ANTEGRADE OPTION, TARGETING GUIDE; INTRAMED FIXATN ROD AND ACCESS

Model Number	ANTEGRADE OPTION, TARGETING GUIDE
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
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 1272-000 was received for investigation.Visual evaluation found that the pin on the "l" side is coming out of its hole.The most likely reason is the wear and tear damage incurred over repeated usage.
Event or Problem Description
On 04/12/2023, it was reported by a sales representative via (b)(4) that an 1272-000 targeting guide peg on the gt to lt targeting attachment is coming out of its hole.This was discovered during a case with no patient effect.

• Brand Name: ANTEGRADE OPTION, TARGETING GUIDE
• Common Device Name: INTRAMED FIXATN ROD AND ACCESS
• 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: 19559035
• Report Number: 1220246-2024-05944
• Device Sequence Number: 4851108
• Product Code: HSB
• UDI-Device Identifier: 00848665013719
• UDI-Public: 00848665013719
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K123569
• 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
• Report Date (Section B): 06/18/2024

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: ANTEGRADE OPTION, TARGETING GUIDE
• Device Catalogue Number: 1272-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 06/18/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown