MAUDE Adverse Event Report: ARTHREX, INC. OBTURATOR FOR AR-6550, AR-6567, AR-6570; ORTHOPEDIC MANUAL SURG INSTR

Model Number	OBTURATOR FOR AR-6550, AR-6567, AR-6570
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 8/8/2023, it was reported by a sales representative via sems that an ar-6549q obturator had an issue.When part number ar-6549q was placed on the black attachment handle, the switching stick didn't pass through.By itself, it worked okay.When all other obturators were loaded onto the black handle, the switching stick passed okay.The procedure was completed successfully with no issues with the patient.This occurred during use in an unspecified procedure with no patient harm.Additional information has been requested.On 8/24/2023, the sales representative provided the following information via email: this occurred during a rotator cuff repair procedure on (b)(6) 2023.The complaint device was used to complete the procedure.No piece of the instrument broke inside the patient, and there was no case delay reported.
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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint is not confirmed.One unpackaged ar-6549q serial/batch number (b)(6) was received for investigation.Functional testing with two mating parts ar-2005nr batch 8482149 found that the returned device attached to the handle without effort and on its own.Visual evaluation found scratches lines around the adapter shaft, and nicks on the color ring.No problem found.

• Brand Name: OBTURATOR FOR AR-6550, AR-6567, AR-6570
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: emily shafer ; 8009337001
• MDR Report Key: 17699505
• Report Number: 1220246-2023-07807
• Device Sequence Number: 6691099
• Product Code: LXH
• UDI-Device Identifier: 00888867402768
• UDI-Public: 00888867402768
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 11/06/2024

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: OBTURATOR FOR AR-6550, AR-6567, AR-6570
• Device Catalogue Number: AR-6549Q
• Device Lot Number: 0072220
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown