MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES GUIDE, CUTTING, DISTAL, MEDIUM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number ROB101396

Device Problem Difficult to Remove (1528)

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

Event Date 12/12/2016

Event Type  Injury  

Event Description

It was reported that during a procedure, when the distal cutting jig was put on and threaded the stabilizer block on, checked the cut with our plane checker, everything was good.The distal cut on the femur was performed.When attempting to unthread the stabilizer block from the distal cut guide it wouldn't unthread.The surgeon used pliers to get it unthreaded - it was very difficult.When we tried to put on the size, block adapter piece wouldn't sit down in the hole.The surgeon did a few light taps and was able to get it seated fully.There was no surgical delay or patient injury.

Manufacturer Narrative

H10: the device was used in treatment and was returned for investigation.The initial visual/functional investigation found that: based on the description in the field report and the damage on the screw and threaded hole, the screw was cross-threaded.This would allow it to be held in place during the cut and then cause it to be very difficult to remove after.Unthreading the cross-threaded screw would cause the damage seen on the thumbscrew and threaded hole.Cross threading would be preceded by a misalignment of the cut guide and stabilizer block.Discussions with clinical reps indicate that these parts are not easily used.The reported complaint was confirmed.The issue was related to design-function of the product.The surgical technique guide released at the time of the complaint provides instructions for distal cut guide assembly, placement, and usage.This failure mode is identified within the risk assessment.Device history record review found the device met the specifications at the date when it was released to distribution.A complaint history review found that this was the first occurrence for this issue.Per complaint details, the device malfunctioned during use.Based on the information provided, there was no patient injury/impact as the procedure was completed with a backup device; therefore, no further medical assessment is warranted at this time.

• Brand Name: GUIDE, CUTTING, DISTAL, MEDIUM
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9989224
• MDR Text Key: 188648494
• Report Number: 3010266064-2020-00282
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ROB101396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Date Manufacturer Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention