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

Catalog Number ROB101397

Device Problems Difficult to Remove (1528); Inadequacy of Device Shape and/or Size (1583)

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

Event Date 12/05/2016

Event Type  malfunction  

Event Description

It was reported that prior to a case, the tka large distal cutting guide screw was stuck and looked stripped.It could not be used.A backup device was available to be used during the procedure.No surgical delay or patient injury reported.

Manufacturer Narrative

H10 h3, h6: the customer reported that the tka large distal cutting guide screw was stuck, looked stripped, and could not be used.The device, used in treatment, was returned investigation.Dhr review found that no conditions that could contribute to the reported event were found.The reported product met manufacturing specifications prior to being released for distribution.A complaint history review found similar reports, this issue will continue to be monitored.Visual and functional inspection of the returned cut guide found no problem.The female threads on the returned material fit with another stabilizer block screw as well as an m6.0 thread gauge.The cut guide was found to be in good working order and was able to be threaded and unthreaded easily.We cannot confirm that there was a relationship established between the reported event and the device because there was no problem found.Factors that could have contributed to the reported issue include if the screw was not properly aligned with the threaded hole or if the screw on the stabilizer block was damaged.Neither can be confirmed or refuted by this investigation.

• Brand Name: GUIDE, CUTTING, DISTAL, LARGE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9989221
• MDR Text Key: 188655371
• Report Number: 3010266064-2020-00281
• 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: 04/22/2020

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ROB101397
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR