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 Wound Dehiscence (1154); Bone Fracture(s) (1870)

Event Date 07/24/2017

Event Type  Injury  

Event Description

It was reported that the patient suffered a femur fracture at the pin site.She came in post-operatively with a displaced supracondylar distal femur fracture and also dehisced her wound that required revision surgery including washing out/poly change/orif of the patient's distal femur.

Manufacturer Narrative

Investigation narrative: based on the x-rays, we are unable to see the exact location of the navio bone screws.The surgeon believed that the line of fracture was through the navio bone screw locations.It is impossible to determine definitively if the bone screw placement did or did not cause the femur fracture, however drilling bone screws through the bone would obviously weaken the bone (expected behavior) and that combined with a fall could cause a fracture.The path through the two screws would be the most likely place for the fracture line as it is the weakest portion of the bone so close to the date of surgery.As of the date of this event, there had only been one other reported instance of bone fracture with navio bone screw use and it was a tibia and the same surgeon performing the case.

Event Description

It was reported that the patient suffered a femur fracture at the pin site.The patient had post-op follow up and showed a displaced supracondylar distal femur fracture and also wound dehiscence that required revision surgery including washing out/poly change/orif of the patient's distal femur.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.A relationship, if any, between the subject device and the reported event could not be determined.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 events.The navio surgical technique for tka (pn 500146 rev a) released at the time of the complaint 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 user's manual also includes instruction for proper bone tracker placement and use of the bone pins.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".Factors that could have contributed to the reported event include weakened bone caused by drilling the screws.

• 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: 6809299
• MDR Text Key: 83195184
• Report Number: 3010266064-2017-00014
• 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

• Date FDA Received: 08/21/2017
• 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
• Date Manufacturer Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR