MAUDE Adverse Event Report: ARTHREX, INC. KOLBEL RETRTR BLADE,36MMX 36MMBLNT; RETRACTOR

Model Number	KOLBEL RETRTR BLADE,36MMX 36MMBLNT
Medical Device Problem Codes	Break (1069); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
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 02/06/2025, a sales representative reported via (b)(6) that an ar-9260-47 kolbel retractor blade, and an ar-9260-46 kolbel retractor blade were damaged.This occurred during a case, with no effect on the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-9260-46 kolbel retractor blade, 36 mm x 36 mm, blunt batch 45552236 was returned for investigation.- visual evaluation noted signs of wear/damage on the body: fading laser marks, chipping marks, and discoloration splotches.- functional testing was not performed due to the damage to the device.- the most likely cause of the reported failure can be attributed to wear and tear, which results from excessive stress on a device that has naturally deteriorated over time due to normal usage and aging.The manufacturing date is 2022.- refer to the investigation photos.- the complaint allegation is confirmed.

• Brand Name: KOLBEL RETRTR BLADE,36MMX 36MMBLNT
• 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: 21420593
• Report Number: 1220246-2025-00562
• Device Sequence Number: 18121112
• Product Code: GFA
• UDI-Device Identifier: 00888867138490
• UDI-Public: 00888867138490
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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 RETRTR BLADE,36MMX 36MMBLNT
• Device Catalogue Number: AR-9260-46
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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