MAUDE Adverse Event Report: ARTHREX, INC. DRILL ATTACHMENT 2.35MM; POWERED SURG ORTHOPEDIC INSTR

Model Number	DRILL ATTACHMENT 2.35MM
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/06/2023
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 (b)(6) 2023, it was reported by a sales representative via sems (b)(4) that (2) ar-300b-2 drill attachments were unable to open up to allow the attachment of a burr.This occurred during a case causing a delay.There was no additional information provided, and additional information has been requested.
Additional Manufacturer Narrative
Additional information: h6 the complaint is confirmed.One unpackaged ar-300b-2 serial/batch number 01364 was received for investigation.Functional testing connecting the burr attachment to the ar-300, sn (b)(6)found no issues attaching the burr and locking into the mating part.Visual evaluation inside the device with a nano camera found that the open/close mechanism is not moving when activated.Signs of wear and tear.The most likely cause(s) for the reported failure is user error per dfu-0223 at revision 0.Important safety conventions.6.Prior to each use, fully assemble the system and press the trigger mechanism to ensure proper function.All couplings and mechanical connections need to be fully secured or locked before the actuation of the system.

• Brand Name: DRILL ATTACHMENT 2.35MM
• Common Device Name: POWERED SURG ORTHOPEDIC 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: 18241899
• Report Number: 1220246-2023-09019
• Device Sequence Number: 12433833
• Product Code: LXH
• UDI-Device Identifier: 00888867202696
• UDI-Public: 00888867202696
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2024

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: DRILL ATTACHMENT 2.35MM
• Device Catalogue Number: AR-300B-2
• Device Lot Number: 15043867
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2023
• 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