MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO HANDPIECE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number PFSR110137

Device Problem Mechanical Jam (2983)

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

Event Date 08/31/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case (b)(4).

Event Description

It was reported that, during set up for a navio assisted tka surgery, it was found that the navio handpiece gears were not moving.Lubricant was used to free the gears but it still did not clear the issue.The procedure was completed with manual instrumentation without significant delays.The patient was not harmed beyond the reported problem.

Manufacturer Narrative

H3, h6: the navio handpiece, part number 110137, serial (b)(6), intended for use in treatment, was returned for evaluation.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.A handpiece diagnostics test was performed.The handpiece failed the t1 torque test, with a torque of 90.The handpiece was then sterilized and retested.The second test yielded a t1 torque of 40.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.The most likely cause of this event is early state motor failure.A historical capa, nc, hhe/pra, field action review was completed.A review of prior escalation actions determined this case and associated lot or serial number is associated with a capa and no further action is required.The surgical technique guide provides a ¿recovery procedure guidelines¿ table that provides guidelines for recovering to a fully manual procedure.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Per complaint details from india it was reported that during set up for a navio assisted tka surgery, it was found that the navio handpiece gears were not moving.Lubricant was used to free the gears but it still did not clear the issue.The procedure was completed with manual instrumentation without significant delays.The patient was not harmed beyond the reported problem.Although no further action will be taken at this time the issue will be continuously monitored through complaint investigation and post market surveillance.

• Brand Name: NAVIO HANDPIECE
• 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: 12601513
• MDR Text Key: 275899676
• Report Number: 3010266064-2021-00711
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628515
• UDI-Public: 00885556628515
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PFSR110137
• Device Catalogue Number: PFSR110137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2022
• 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: ROB00036-NAVIO SURGICAL SYSTEM INDIA
• Patient Outcome(s): Other