MAUDE Adverse Event Report: ACUMED, LLC STABLELOC EXTERNAL FIXATOR KIT; COMPONENT, TRACTION, INVASIVE

Model Number FX-4001-S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2022

Event Type  malfunction  

Manufacturer Narrative

The returned product was examined under magnification.The items returned from the stableloc external fixator kit were: stableloc assembly (pn fx-4000) batch #398301, stableloc hex driver (pn fx-4003) batch #396624, stableloc 25mm external drill guide (pn fx-4002) batch #398094, stableloc pin driver (pn fx-4008) batch #398559, 2.5mm stableloc pilot drill (pn fx-4006) batch #369689.The ballshaft of the stableloc assembly was broken.From the visible area, it appeared the ball shaft had fractured inside of the housing across the section where the screw hole was located.The ball shaft locking screw was returned that interfaces with the fractured hole.The ball shaft locking screw showed scraping at the non-threaded section below the head as well as multiple damaged and deformed screw threads near the tip of the screw.No other significant signs of damage were observed.Minor signs of wear and damage observed included: slight deformation of the edges of the hex on the driver, some scrapes and dents on the ball joint cap of the stableloc assembly, curved wear in the corners of the pin driver where it interfaces with the pins and some minor scrapes around the holes of the drill guide.Based on the information received and the investigation performed, the root cause could not be determined.

Event Description

It was initially reported during the procedure, the dial to adjust the flexion could not be loosened by hand.The surgeon used pliers to loosen it.The ballshaft locking screw popped out on the device itself and no one could put it back in.Potentially something was misalgined when it was put together.The pins from the stableloc were left in, and the surgery was completed with a carbon rod from a different company.Further information received regarding the event indicated attempts were made to tighten the bolt but it kept spinning, and it was noticed "it was broken".This issue resulted in a 20 minute procedural delay to extract the device, and a different kit was used to complete the procedure.There were no adverse patient consequences reported, and the patient remained stable during the procedure depsite the delay.

• Brand Name: STABLELOC EXTERNAL FIXATOR KIT
• Type of Device: COMPONENT, TRACTION, INVASIVE
• Manufacturer (Section D): ACUMED, LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: ellie wood ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 5035209618
• MDR Report Key: 15060711
• MDR Text Key: 298036004
• Report Number: 3025141-2022-00226
• Device Sequence Number: 1
• Product Code: JEC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K965029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/18/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2024
• Device Model Number: FX-4001-S
• Device Catalogue Number: FX-4001-S
• Device Lot Number: 402580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2022
• Initial Date FDA Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2017
• 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 Age: 72 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White