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

Model Number FIBULOCK IMPLANT SYSTEM, STERILE

Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/23/2019

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 remaining 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, the surgeon was using a fibulock implant system, ar-8973ds.After drilling, the initial k-wire snapped off.The device and its broken piece were retrieved and a second k-wire was used.During over-drilling for the nail with the 3.2 reamer, the second k-wire snapped.The k-wire was left in the fibula canal and was irretrievable.Additional information provided 4/26/2019: the surgeon completed the case using an ankle fracture playing set.Roughly 25% of the wire was left in the fibula.

• 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: 8611802
• MDR Text Key: 145129951
• Report Number: 1220246-2019-01099
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: FIBULOCK IMPLANT SYSTEM, STERILE
• Device Catalogue Number: AR-8973DS
• Device Lot Number: 10282319
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/25/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/27/2019
• 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