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	05/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 6/3/2024 it was reported by a sales representative via (b)(4) that an ar-9260-45 kolbel retractor had a broken ratchet with no adverse effects on the patient and no fragments from the broken device.The case was completed with another ar-9260-45 kolbel retractor with no issues.This was discovered during a reverse shoulder arthroplasty procedure on (b)(6) 2024, with no reported patient harm.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Upon visual inspection, it was noted that the rachet between the handles was broken off.The device showed scratches and nicks around it.The laser marks were faded.Functional testing was not performed due to the damage to the device.The most likely cause of this failure is attributed to wear and tear damage incurred over repeated usage.

• 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: 19615844
• Report Number: 1220246-2024-06427
• Device Sequence Number: 6140721
• Product Code: MDM
• UDI-Device Identifier: 00888867138483
• UDI-Public: 00888867138483
• 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): 09/19/2024

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: KOLBEL RETRACTOR, 8" LONG, RING HANDLE
• Device Catalogue Number: AR-9260-45
• Device Lot Number: 45552211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2022
• 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