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

Model Number FIBULOCK IMPLANT SYSTEM, STERILE

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/10/2019

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The retrieved portion of the device was reported to have been discarded.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported that during an ankle fx procedure, as the surgeon was inserting the guidewire that's included in the fibulock implant system, ar-8793ds, the gold tip broke off.The tip was unable to be retrieved from the patient as it was lodged within the bone canal.As the surgeon attempted to insert the fibluock nail, he found difficulty reaming past the broken fragment.He was eventually able to push the fragment to the side and insert the fibulock nail.A delay of approximately 20 min incurred due to the broken fragment.

• Brand Name: FIBULOCK IMPLANT SYSTEM, STERILE
• Type of Device: 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: 9289814
• MDR Text Key: 182469708
• Report Number: 1220246-2019-01401
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00888867303041
• UDI-Public: 00888867303041
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FIBULOCK IMPLANT SYSTEM, STERILE
• Device Catalogue Number: AR-8973DS
• Device Lot Number: 10342579
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other