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

Model Number PFSR110164

Device Problem Solder Joint Fracture (2324)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference case: (b)(4).Postal code: (b)(6).

Event Description

It was reported that during a navio assisted tka surgery, the navio bone screw driver spins freely, does not grip and drive the pin.The procedure was completed, with a non-significant delay, using a s+n back-up device.Patient was not harmed beyond the problem reported.

Manufacturer Narrative

Additional info in: d, g, h results of investigation: the navio bone screw driver pfsr110164, lot 8016483 (united kingdom) used for treatment was returned for evaluation.A relationship between the reported event and the device was established.The reported problem was visually confirmed.The driver has separated from the pin driver body.A functional evaluation was not required as the reported problem was confirmed visually.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints found similar events.As part of our continued process improvement a review of prior escalation actions has determined that this case and associated lot / serial number is related to a corrective/preventive action, nonetheless, no containment has been required.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.The most likely cause of this event is mechanical component failure and breakdown/defect of the weld.Further investigation into the reported failure has been conducted, and the potential root cause is a combination of durability issues after extended use (expected wear and tear rate), abnormal use of the tools, or inherent variations in the manual weld process that are present across production lots.The investigation was closed with appropriate risk justification and objective evidence that led to the potential root causes listed above.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• 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
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13088028
• MDR Text Key: 286743561
• Report Number: 3010266064-2021-00906
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628614
• UDI-Public: 00885556628614
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2022

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
• Device Lot Number: 8016483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 12/27/2021
• Supplement Dates Manufacturer Received: 02/09/2022
• Supplement Dates FDA Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ROB00049-NAVIO SURGICAL SYSTEM UK