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

Model Number FX-4001-S

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/23/2019

Event Type  malfunction  

Manufacturer Narrative

The stableloc external fixator assembly (pn:fx-4000 /batch#467981) was inspected upon its return.Even upon removal of the set screw, the ball joint is not able to freely rotate.The examination of the ball joint showed damage to the anodization layer of the ball joint.Lost material may become stuck in the joint housing prohibit full range of motion.

Event Description

While using a stableloc external fixator kit, the spherical joint failed and the device could not be used.As a result of this issue, there was a 15 minute delay in surgery.

• Brand Name: STABLELOC EXTERNAL FIXATOR KIT
• Type of Device: COMPONENT, TRACTION, INVASIVE: STABLELOC
• 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: micki anderson ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 8886279957
• MDR Report Key: 9489876
• MDR Text Key: 183714486
• Report Number: 3025141-2019-00635
• Device Sequence Number: 1
• Product Code: JEC
• Combination Product (y/n): N
• Reporter Country Code: CS
• PMA/PMN Number: K965029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/25/2019

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 Model Number: FX-4001-S
• Device Catalogue Number: FX-4001-S
• Device Lot Number: 470155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2019
• 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