MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NDI CAMERA POLARIS SPECTRA; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number PFSR200027

Device Problems Device Difficult to Program or Calibrate (1496); Intermittent Communication Failure (4038)

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

Event Date 09/29/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference case- (b)(4).Initial reporter postal code (b)(6).

Event Description

It was reported that, during a navio sales training, they received a tracking failure of camera upon start up.It progressed as green through ankle collection but as circumduction of hip occurred, tracking failure error came up and camera remained in warming phase.They restarted several times and same error occurred.They tested on alternative navio system and same error happened.No case involved; therefore, there was no patient involvement.

Manufacturer Narrative

The ndi camera polaris spectra intended for use in treatment was returned for evaluation.A relationship between the reported event and the device was established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was completed.The reported problem was confirmed.Upon startup, a tracking failure of camera was received.The camera was connected to a navio system and a case created.The camera infrared failure error displayed and the camera remained in warming phase.An event file assessment was completed.The reported problem was confirmed.The event log identified numerous illuminator current faults.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.The most likely cause of these events is an electrical failure of the internal infrared camera led board.The camera is an oem product and cannot be disassembled further to arrive at a root cause.A historical capa, hhe/pra, field action review was completed.A review of prior escalation actions found no actions applicable to the scope of this case.The failure mode and associated risk have been anticipated within the risk file and that the documented risk level is still adequate.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.

Manufacturer Narrative

The ndi camera polaris spectra intended for use in treatment was returned for evaluation.A relationship between the reported event and the device was established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was completed.The reported problem was confirmed.Upon startup, a tracking failure of camera was received.The camera was connected to a navio system and a case created.The camera infrared failure error displayed and the camera remained in warming phase.An event file assessment was completed.The reported problem was confirmed.The event log identified numerous illuminator current faults.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.The most likely cause of these events is an electrical failure of the internal infrared camera led board.The camera is an oem product and cannot be disassembled further to arrive at a root cause.A historical capa, hhe/pra, field action review was completed.A review of prior escalation actions found no actions applicable to the scope of this case.The failure mode and associated risk have been anticipated within the risk file and that the documented risk level is still adequate.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.

• Brand Name: NDI CAMERA POLARIS SPECTRA
• 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: 12697600
• MDR Text Key: 278372212
• Report Number: 3010266064-2021-00727
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556649541
• UDI-Public: 885556649541
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PFSR200027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2022
• 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: NAVIO SURGICAL SYSTEM SOUTH AFRICA, (B)(6).; NAVIO SURGICAL SYSTEM SOUTH AFRICA, (B)(6).; ROB00037-NAVIO SURGICAL SYSTEM SOUTH AFRICA; ROB00037-NAVIO SURGICAL SYSTEM (B)(6)