MAUDE Adverse Event Report: ARTHREX, INC. KOLBEL RETRACTOR, 8" LONG, RING HANDLE

Model Number	KOLBEL RETRACTOR, 8" LONG, RING HANDLE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 06/19/2025, a sales representative reported via (b)(4) that an ar-9260-45 8¿ ring handle kolbel retractor spring broke and no longer sticks.A case was involved, and no patient was harmed.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.One unpackaged ar-9260-45, kolbel retractor, 8'' long, batch 45552321, was received for investigation.Upon visual inspection, the screw and lever were missing from one of the ring handles.Functional testing was not performed due to the damage to the device.The most likely cause of this failure is normal wear and tear damage incurred during repeated and extended use in the field.Manufactured date 2023.The complaint allegation is confirmed.

• Brand Name: KOLBEL RETRACTOR, 8" LONG, RING HANDLE
• Common Device Name: RETRACTOR
• 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: 22511601
• Report Number: 1220246-2025-02891
• Device Sequence Number: 8745632
• Product Code: MDM
• UDI-Device Identifier: 00888867138483
• UDI-Public: (01)00888867138483(11)230613(10)45552321
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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: KOLBEL RETRACTOR, 8" LONG, RING HANDLE
• Device Catalogue Number: AR-9260-45
• Device Lot Number: 45552321
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown