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

Model Number	3.0X130MM FIBULA NAIL, RIGHT
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/04/2022
Type of Reportable Event	Serious Injury
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 7/28/2022 it was reported by a sales representative via sems that an ar-8973r-30-130 fibula nail has no 60 degree bend.The nail was straight.This was discovered during a fibula fracture procedure.The nail was implanted but did not fit because there was no bend.The surgeon removed it and closed the case without having fixation on the fibula side.

• Brand Name: 3.0X130MM FIBULA NAIL, RIGHT
• 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: 15242838
• Report Number: 1220246-2022-05391
• Device Sequence Number: 4748364
• Product Code: HSB
• UDI-Device Identifier: 00888867295216
• UDI-Public: 00888867295216
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 08/17/2022

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: 3.0X130MM FIBULA NAIL, RIGHT
• Device Catalogue Number: AR-8973R-30-130
• Device Lot Number: 11025405
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 08/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown