MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO BONE PIN 4.0MMX152MM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	ROB00031
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that at the end of a tka surgery, the navio bone pin 4.0mmx152mm failed just above the black ring.From the photo provided, it was noticed broken at the top.It happened while in use inside the patient and there was no need of back-up.The procedure was completed, with a non-significant delay.
Additional Manufacturer Narrative
Additional info in: d, g, h results of investigation: the navio bone pin 4.0mmx152mm (united kingdom) product rob00031, used for treatment was not made available to the designated complaint unit for evaluation, however a photo was provided for evaluation.A relationship between the reported event and the device was confirmed.The bone pin appears to be broken at the top above the black ring.A functional evaluation could not be performed because the device was not returned.While all products meet required manufacturing specifications prior to release a legible serial number or lot number is required to link the device to a device history record or non conformance investigation.A complaint history review for similar reported/confirmed complaints found similar events.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of this case.The most likely cause of this event is surgical technique.The navio surgical technique guide provides instructions for proper insertion and correct placement of bone pins.This failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Per complaint details from the united kingdom, it was reported that at the end of a tka surgery, the navio bone pin 4.0mmx152mm failed just above the black ring.It happened while in use inside the patient and there was no need of back-up.The procedure was completed, with a non-significant delay.No patient injury or impact was reported, hence no medical records were provided.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.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: NAVIO BONE PIN 4.0MMX152MM
• Common Device Name: 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: 13080449
• Report Number: 3010266064-2021-00900
• Device Sequence Number: 12264470
• Product Code: OLO
• UDI-Device Identifier: 00885556685310
• UDI-Public: 00885556685310
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ROB00031
• Device Catalogue Number: ROB00031
• Device Lot Number: 21FT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 12/23/2021
• Supplement Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROB00049, NAVIO SURGICAL SYSTEM UK
• Patient Sex: Unknown