MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES SCREW, BONE, 4 MM OD X 5.0 (127 MM) IN LG, STRIDE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number NPFS02000

Device Problems Device Operates Differently Than Expected (2913); Device Operational Issue (2914); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 08/15/2017

Event Type  Injury  

Event Description

It was reported that while drilling the tibial bone pins he heard a "crack".Could have been due to aggressive drilling and drilling pins through the posterior cortex.The patient was put on non weight bearing bed rest in order to avoid further damage.

Manufacturer Narrative

Updated evaluation codes.Investigation narrative: the post-op x-rays did not show any tibial fracture near the insertion sites of the bone screws.The x-ray did, however, show that the posterior exit hole of the bone screw appeared to be the full diameter, indicating that the surgeon drilled the screw entirely through the posterior cortex as opposed to only engaging it (as prescribed in the ifu).It is likely that the audible "crack" heard was the bone screw breaking through the posterior cortex and not a fracture.

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 while drilling the tibial bone pins, the surgeon heard a "crack".It could have been due to aggressive drilling and drilling pins through the posterior cortex.The patient was put on non-weight bearing bed rest in order to avoid further damage.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h3, h6: the reported device, used for treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.Review of the post-operative x-rays provided by the site and did not show any tibial fracture near the insertion sites of the bone screws.The x-ray did reveal that the posterior exit hole of the bone screw appeared to be the full diameter.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.A complaint history review identified prior similar event.The navio surgical technique for tka (pn 500146 rev a) released at the time of the complaint includes instruction for proper bone tracker placement and use of the bone pins.In the "bone tracking hardware" section, it notes to "slowly drill the bone pin into the tibia, perpendicular to the bony surface, taking care to engage the opposing cortex and stop." the surgical technique also 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".We were able to confirm there was a relationship established between the reported event and the device.There was no evidence that any patient injury or user error occurred as a result of the reported event.Review of the post-operative x-rays provided by the site did not show any tibial fracture near the insertion sites of the bone screws.The x-ray did reveal that the posterior exit hole of the bone screw appeared to be the full diameter.No problem found.

• Brand Name: SCREW, BONE, 4 MM OD X 5.0 (127 MM) IN LG, STRIDE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest; blvd ste 40; plymouth, mn MN 55441
• MDR Report Key: 6916366
• MDR Text Key: 88247815
• Report Number: 3010266064-2017-00015
• 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,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?: No
• Device Operator: Health Professional
• Device Model Number: NPFS02000
• Device Catalogue Number: PFSD101111
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/05/2017
• Initial Date FDA Received: 10/05/2017
• Supplement Dates Manufacturer Received: 09/05/2017; 08/15/2017; 08/11/2020
• Supplement Dates FDA Received: 06/13/2018; 04/23/2020; 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR