MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO CHECKPOINT VERIFICATION PINS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number PFSD01009

Device Problem Off-Label Use (1494)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/23/2020

Event Type  Injury  

Event Description

It was reported that, during the second leg of a bilateral knee surgery using the navio surgical system, the surgeon wanted to make a cementing augment after final long-leg alignment verification.The surgeon used one checkpoint pin to assist with the cement augmentation, although this is not the use for this reusable device.The surgeon was advised that the construct was stainless steel and was not compatible with the cobalt chrome component.The piece is still implanted.It is unknown the current status of the patient.

Manufacturer Narrative

H3, h6: the navio checkpoint verification pin, part number pfsd01009, used for treatment was not returned for evaluation; thus, a visual and functional evaluation could not be performed, and a relationship between the reported event and the device could not be determined.While all products meet required manufacturing specifications prior to release a serial number or lot number is required to link the device to a dhr or nc investigation.A complaint history review for similar reported/confirmed complaints concluded this was an isolated event.Although the reported problem was not confirmed, a factor that may have contributed to the reported symptom may have been associated with improper use/handling of the part.The navio surgical technique guide (500197) provides instructions to finish the implantation of the final components, as recommended in the applicable implant surgical technique, using appropriate instruments and tools.This failure is an identified failure mode within the risk assessment.This complaint from australia reports that the surgeon used navio checkpoint verification pins after being advised that the construct was stainless steel and was not compatible with the cobalt chrome component.No patient injury or impact was reported and the patient and surgeon were satisfied with the surgical outcome.Smith & nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received the complaint can be reopened.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.Additional information: d3.

• Brand Name: NAVIO CHECKPOINT VERIFICATION PINS
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10701155
• MDR Text Key: 212074389
• Report Number: 3010266064-2020-01888
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628720
• UDI-Public: 00885556628720
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/17/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: PFSD01009
• Device Catalogue Number: PFSD01009
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/19/2020
• Supplement Dates Manufacturer Received: 08/16/2021
• Supplement Dates FDA Received: 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other