MAUDE Adverse Event Report: ARTHREX, INC. GUIDE WIRE GRIPPER; INTRAMED FIXATN ROD AND ACCESS

Model Number	GUIDE WIRE GRIPPER
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 08/12/2025, it was reported by a sales representative via (b)(4) that a 0481-100 guide wire gripper handle would not stay closed or clamped while the surgeon was malleting wire down the tibia canal.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged 0481-100 batch 211598 was received for evaluation.Upon visual inspection, discoloration was observed throughout the device.Functional testing was conducted by operating the device¿s open and closed ratchet mechanism.The ratchet exhibited signs of weakness and functional deficiencies, as it felt loose during operation.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.

• Brand Name: GUIDE WIRE GRIPPER
• 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: 22921259
• Report Number: 1220246-2025-03673
• Device Sequence Number: 18432234
• Product Code: HSB
• UDI-Device Identifier: 00848665010596
• UDI-Public: (01)00848665010596(11)210819(10)211598
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K132005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2025

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: GUIDE WIRE GRIPPER
• Device Catalogue Number: 0481-100
• Device Lot Number: 211598
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown