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, METAL/POLYMER

Model Number NPFS02000

Device Problems Fracture (1260); Device Operational Issue (2914)

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

Event Date 02/02/2018

Event Type  Injury  

Event Description

It was reported that while removing the tibial bone pins, the head of the most distal pin snapped off in the pin driver.The surgeon was unable to use the pin driver again and used the t-wrench to remove the other pins.After trying a power drill, wire driver, and vice grip without success, a 4.5mm cannulated drill was used to drill into the bone around the screw to remove it.

Manufacturer Narrative

The bone screw was discarded by hospital staff, therefore there is no material to evaluate.The user supplied a video showing the bone screw being removed with a cannulated drill bit and the difficulty piercing the bone.The surgeon noted to the representative that the bone was "very hard".The follow-up report received from the surgeon's assistant indicated that the patient did not have any abnormal pain or present any other concerning symptoms during the follow-up visit.The issue observed during this case does not show any indications of a part defect and may be related to patient bone quality.

Manufacturer Narrative

Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.

Event Description

It was reported that when the tibial bone pins were being removed, the head of the most distal pin snapped off in the pin driver.Pin driver could not be used again, had to use the t-wrench to remove the other pins.The surgeon had to use a 4.5mm canulated drill to drill into the bone around the screw to remove it.

Manufacturer Narrative

H10, h3, h6: the device, used for treatment, was not returned for evaluation.The site provided a video of the bone pin being removed with a cannulated drill, and the user's difficulty piercing the bone.The surgeon noted that the patient's bone was "very hard".The video provided did not indicate any part defects and follow up report from the site indicated that the patient did not have any abnormal pain or present any other concerning symptoms during the follow up.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.Thus, the reported products met manufacturing specifications prior to being released for distribution.A complaint history review found prior similar reports, this issue will continue to be monitored.The navio surgical technique for tka released at the time of the complaint on page 3 states that the navio instrument kit consists of a two-level tray that contains the required instrumentation for any navio¿ surgical system tka procedure.The surgical technique guide also includes instruction for proper bone tracker placement and use of the bone pins.The surgical technique guide cautions: "warning: be sure to place the proximal bone pin as directed.If placed too close to the tibial plateau, it may interfere with placement of the tibial implant component, causing damage to the bone pin and possible patient harm".This failure mode is identified within the risk assessment.We were not able to confirm if there was a relationship established between the reported event and the device.The malfunction occurred when the head of the most distal pin snapped off in the pin driver while removing the tibia bone pins.The bone pin had to be removed with a cannulated drill and the t-wrench was used to remove the other pins.The site provided a video of the bone pin being removed with a cannulated drill, and the user's difficulty piercing the bone.The surgeon noted that the patient's bone was "very hard".There was no evidence of user error or a device defect.

• Brand Name: SCREW, BONE, 4 MM OD X 5.0 (127 MM) IN LG, STRIDE
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; suite 40; plymouth, mn MN 55441
• MDR Report Key: 7315498
• MDR Text Key: 101722802
• Report Number: 3010266064-2018-00003
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NPFS02000
• Device Catalogue Number: 101111
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/02/2018
• Initial Date FDA Received: 03/05/2018
• Supplement Dates Manufacturer Received: 02/02/2018; 02/02/2018; 08/11/2020
• Supplement Dates FDA Received: 10/26/2018; 04/22/2020; 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BONE SCREW (PN 101111)
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR