MAUDE Adverse Event Report: ARTHREX, INC. FIBULOCK IMPLANT SYSTEM, STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	FIBULOCK IMPLANT SYSTEM, STERILE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2022
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 06/02/2022 it was reported by a sales representative via sems that an ar-8973ds fibulock implant system had an issue.While performing the fibulock procedure on (b)(6) 2022, the surgeon had difficulty advancing the 6.2mm reamer over the 1.6mm wire, even while applying force.The 1.6mm wire snapped in the canal after having difficulty advancing the 6.2mm reamer and the surgeon had to bail to a plate.The wire fragment was left in the canal.The case was completed successfully.This was discovered during use with no impact to the patient.On (b)(6) 2022, the sales representative stated the following information via phone: the distal reamer 6.2mm was very difficult to advance into the distal fibula, not spinning very well.The guide wire snapped, the fragment was left in the canal, and the fracture was plated instead with an ar-8943bl or bs lock distal fibula plate, the exact part, and lot number were unknown.This resulted in a deviation from the intended procedure, and the case was completed successfully that way, and the patient was fine to date.The snapped part of the wire was left in the patient, and the rest of the complaint device was discarded by the facility.

• Brand Name: FIBULOCK IMPLANT SYSTEM, STERILE
• 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: 14744274
• Report Number: 1220246-2022-05116
• Device Sequence Number: 2215214
• Product Code: HSB
• UDI-Device Identifier: 00888867303041
• UDI-Public: 00888867303041
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/20/2022

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: FIBULOCK IMPLANT SYSTEM, STERILE
• Device Catalogue Number: AR-8973DS
• Device Lot Number: 14942294
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 06/20/2022
• Date Device Manufactured: 03/22/2022
• 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