MAUDE Adverse Event Report: ARTHREX, INC. 3.0X130MM FIBULA NAIL, LEFT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3.0X130MM FIBULA NAIL, LEFT
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/30/2022
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 5/31/2022, it was reported by a sales representative via email that an ar-8973l-30-130 arthrex fibulock nail tip broke.The surgeon inserted the nail after reaming and because it was not inserting easily, surgeon gave it two light taps with a mallet.After seeing the nail was not moving, surgeon reamed again and when the nail was pulled out, the tip was broke off just above the talons and still inside the patient.Surgeon was able to push it out of the way with the reamer and complete the procedure with a second nail.This was discovered during a procedure on (b)(6) 2022.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-8973l-30-130 nail assembly was received for investigation.Visual inspection identified that the tension screw was not returned within the nail construct.Analysis under magnification revealed that the prongs at the distal tip of the nail had broken.No fragments were returned for assessment.Due to the returned condition of the distal tip, no accurate measurements could be taken.The od of the nail body was assessed using digital micrometer id: (b)(4), and met design specifications.The cause remains undetermined.A likely cause is attributed to the malleting applied to the device as referenced in the event description.

• Brand Name: 3.0X130MM FIBULA NAIL, LEFT
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 14742763
• Report Number: 1220246-2022-05096
• Device Sequence Number: 4677130
• Product Code: HSB
• UDI-Device Identifier: 00888867295209
• UDI-Public: 00888867295209
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173656
• 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): 07/19/2022

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 Expiration Date: 08/31/2026
• Device Model Number: 3.0X130MM FIBULA NAIL, LEFT
• Device Catalogue Number: AR-8973L-30-130
• Device Lot Number: 14054654
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 06/20/2022
• Supplement Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown