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	10/25/2023
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 10/25/2023, it was reported by a sales representative via (b)(4) that an ar-6549q obturator would not fit down the commutation of 7x7 cannula and would stop around 2/3 way down.The device was tried on several cannulas.This was discovered during a rotator cuff procedure.The case was completed by using a new device with no patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 -one unpackaged ar-6549q obturator lot: 0072220 was received for investigation.-visual evaluation noted no problems with the device.-functional testing was performed by inserting the ar-6549q obturator into an ar-6550 twist-in cannula and it was found that the obturator was able to be completely inserted and would sit flush against the twist-in cannula.-no problem found.-refer to investigation photos.-complaint allegation is not confirmed.

• 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: 18182304
• Report Number: 1220246-2023-08837
• Device Sequence Number: 12675783
• Product Code: LXH
• UDI-Device Identifier: 00888867402768
• UDI-Public: 00888867402768
• 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): 08/26/2024

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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