MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES SCREW, BONE, 4 MM OD X 5.0 (127 MM) IN LG, STRIDE; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED

Catalog Number 101111

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2019

Event Type  Injury  

Event Description

It was reported that during a tka procedure, the pin broke off in the navio distal cut block.The block was removed from bone but the pin could not be removed from cutting guide.There was a delay of less than 30 min with no patient injury.According to investigation, the pin used was not the one prescribed in the surgical technique for tka.

Manufacturer Narrative

H10: the device, used in treatment, was returned for investigation.A complaint history review found similar reports, this issue will continue to be monitored.A review of the device history record found that for all lots for this part number, all of the quantity received was accepted with no other issues that would potentially lead to a future performance issue.This failure is an identified failure mode within the risk file.The surgical technique guide released at the time of the complaint provides instructions for using the cut guide.Specifically, the guide does provide instruction on how to secure the distal cut guide on the bone surface using 1/8" diameter non-rimmed speed pins provided in the smith & nephew implant system trays.The visual inspection found that the pin used was not the prescribed 1/8th diameter nonrimmed speed pin as required in the surgical technique for tka.The pin used was threaded and pointed, causing it to be lodged through the cut block then bending and breaking.The probable cause for this issue was user error of the wrong pin.Per complaint details, the system malfunctioned during use; the pin broke off in navio distal cut block the surgeon could not get pin out of the block.Based on the information provided of the less than 30 minutes delay, inconvenience and swapping out the equipment; no patient injury/impact was concluded.Therefore, no further medical assessment is warranted at this time.

• Brand Name: SCREW, BONE, 4 MM OD X 5.0 (127 MM) IN LG, STRIDE
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9996578
• MDR Text Key: 188858777
• Report Number: 3010266064-2020-00964
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K123380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• 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: 04/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 101111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Date Manufacturer Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1