MAUDE Adverse Event Report: Arthrex, Inc. DISTAL DRILL GUIDE, Ø4.0mm; INTRAMED FIXATN ROD AND ACCESS

Model Number	DISTAL DRILL GUIDE, Ø4.0mm
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, it was reported by a sales representative via (b)(6) that a 1268-100 targeting arm and 0315-100 drill guide are no longer targeting.Noticed during a case with no patient effect.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
-complaint allegation is confirmed.-visual evaluation of the 4.0mm distal drill guide, locking assembly, noted that the edge of the distal end of the shaft and green lever was chipped.Laser marking was observed to be faded.-functional testing was performed and noted that the spring did not function as required.The most likely cause of the reported failure can be attributed to wear and tear damage resulting from repeated insertion/removal/cleaning processes and extended use of the device in the field.

• Brand Name: DISTAL DRILL GUIDE, Ø4.0mm
• Common Device Name: INTRAMED FIXATN ROD AND ACCESS
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50473398
• Report Number: 1220246-2026-04504
• Device Sequence Number: 16011080
• Product Code: HSB
• UDI-Device Identifier: 00848665001440
• UDI-Public: (01)00848665001440(11)240528(10)240620
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K132005
• 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): 08/27/2026

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: DISTAL DRILL GUIDE, Ø4.0mm
• Device Catalogue Number: 0315-100
• Device Lot Number: 240620
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2024
• 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