MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO BONE SCREW DRIVER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number PFSR110164

Device Problems Break (1069); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2019

Event Type  malfunction  

Event Description

It was reported that during surgery, the inside piece of the bone pin driver popped out.Delay of less than 30 minutes and back-up device was available.No patient injuries reported.

Manufacturer Narrative

The device was returned for evaluation.The exterior condition shows minor wear (scratches).Nothing was identified visually that contributed to the reported problem.Functional evaluation was performed.The pin driver was attached to a bone pin and an attempt was made to turn/rotate the bone pin.The pin driver failed to turn/rotate the bone pin because the inner driver is no longer attached to the pin driver.A review of manufacturing records found no related non-conformances or anomalies associated with this device during production.Therefore the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints associated with the pin driver and failure mode(s) identified similar events.The most likely cause of this event is mechanical component failure and breakdown/defect of the weld.Navio user manual 500197 rev b indicates "using the bone pin driver and a surgical drill: 5.Drill the first bone pin through the tissue protector, perpendicular to the surface of the bone, taking care to only engage, and not perforate, the opposing cortex." drilling perpendicular is recommended when using the pin driver.No further containment or corrective actions are recommended at this time.

Manufacturer Narrative

Results of investigation have been corrected as follows: the device was returned for evaluation.The exterior condition shows minor wear (scratches).Nothing was identified visually that contributed to the reported problem.Functional evaluation was performed.The pin driver was attached to a bone pin and an attempt was made to turn/rotate the bone pin.The pin driver failed to turn/rotate the bone pin because the inner driver is no longer attached to the pin driver.A review of manufacturing records found no related non-conformances or anomalies associated with this device during production.Therefore the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints associated with the pin driver and failure mode identified similar events.The most likely cause of this event is mechanical component failure and breakdown/defect of the weld.This issue is being further investigated under corrective action.

• Brand Name: NAVIO BONE SCREW DRIVER
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 9998570
• MDR Text Key: 189488070
• Report Number: 3010266064-2020-01317
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628614
• UDI-Public: 00885556628614
• 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
• Report Date: 08/19/2020

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?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PFSR110164
• Device Catalogue Number: PFSR110164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2019
• Date Manufacturer Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1