MAUDE Adverse Event Report: ARTHREX, INC. BUR,OVAL,SJ,10 FLUT,3.0MMX 7CM; BURR,SURGICAL

Model Number	BUR,OVAL,SJ,10 FLUT,3.0MMX 7CM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2024
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
It was reported that during an arthroscopic surgery of the ankle the device broke.The device broke inside the patient but all parts were retrieved.There was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint allegation was confirmed.One unpackaged ar-7300obt, batch/serial number (b)(6), was received for evaluation.Upon visual inspection, the device's outer tube was bent.After removing the inner tube, it was observed that it had broken off, with only a portion of the inner tube shaft remaining attached to the hub.Functional testing was not performed as the device was broken.A user error is the most likely cause(s) for the reported and observed failure, hitting the device with another device or object, prying/leveraging, or excessive bending forces applied during use.

• Brand Name: BUR,OVAL,SJ,10 FLUT,3.0MMX 7CM
• Common Device Name: BURR,SURGICAL
• 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: 19562861
• Report Number: 1220246-2024-06018
• Device Sequence Number: 20720399
• Product Code: GFF
• UDI-Device Identifier: 00888867041950
• UDI-Public: 00888867041950
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2024

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: BUR,OVAL,SJ,10 FLUT,3.0MMX 7CM
• Device Catalogue Number: AR-7300OBT
• Device Lot Number: 15080040
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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