MAUDE Adverse Event Report: ARTHREX, INC. MINIMALLY INVASIVE BUNION DRILL GUIDE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	MINIMALLY INVASIVE BUNION DRILL GUIDE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/03/2023
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
It was reported on (b)(6) 2023 by a sales representative via sems that an ar-8741g-02 positioning knob would not screw into the ar-8741g drill guide."the screw positioning knob for the bunionectomy minimally invasive bunion guide was not able to be screwed in fully in the correct location - screw is either defective or the c ring guide is defective.It caused the case to go an hour longer than usual." case involvement, deviation from procedure occurred.
Additional Manufacturer Narrative
Complaint is confirmed.One unpackaged ar-8741g mis bunion guide serial/batch number (b)(6) was received for investigation.Functional testing found the positioning knob screw are not screwing into the main bracket.Visual evaluation found that the screws and the cannular guide body are damaged.Many gouges were observed on the peek screw threaded holes.The root cause of the reported failure mode is undetermined.However, the most likely probable cause is applying excessive mechanical forces upon insertion/use.

• Brand Name: MINIMALLY INVASIVE BUNION DRILL GUIDE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16427663
• Report Number: 1220246-2023-06336
• Device Sequence Number: 2621763
• Product Code: LXH
• UDI-Device Identifier: 00888867362673
• UDI-Public: 00888867362673
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MINIMALLY INVASIVE BUNION DRILL GUIDE
• Device Catalogue Number: AR-8741G
• Device Lot Number: 052111
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2023
• Supplement Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown