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

Model Number PFSR110164

Device Problem Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Date 01/10/2020

Event Type  malfunction  

Event Description

It was reported that before a tka procedure, the bone pin driver was found stripped and would not hold bone pins.No patient involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device was returned for evaluation.The exterior condition shows minor wear (scratches).The reported problem was confirmed.The driver has separated from the main body.A functional evaluation could not be performed due to broken/damaged parts.The driver has separated from the main body.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).The reported problem was confirmed.The driver has separated from the main body.A functional evaluation could not be performed due to broken/damaged parts.The driver has separated from the main body.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) "damaged or broken component" 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: 9999467
• MDR Text Key: 189159970
• Report Number: 3010266064-2020-01455
• 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,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 01/22/2020
• Initial Date Manufacturer Received: 01/10/2020
• Initial Date FDA Received: 04/26/2020
• Supplement Dates Manufacturer Received: 07/14/2020; 07/31/2020
• Supplement Dates FDA Received: 07/15/2020; 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1