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

Model Number	ROB00031
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during machine set up for a navio-assisted surgery, it was found that the navio bone pin 4.0mmx152mm (b)(4), the navio bone pin 4.0mm x 127mm (b)(4) and the navio handpiece thumberscrew (b)(4) had lost the threadings.No delays were reported.It is unknown how the procedure was completed.Patient outcome is unknown.
Additional Manufacturer Narrative
The navio bone pin, part rob00031 used for treatment was not made available to the designated complaint unit for evaluation thus, a visual and functional evaluation could not be performed and a relationship between the reported event and the device could not be determined.While all products meet required manufacturing specifications prior to release a serial number or lot number is required to link the device to a dhr or nc investigation.A complaint history review for similar reported/confirmed complaints has identified prior events.Although the reported problem was not confirmed, a contributing factor may be natural wear and tear.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.
Event or Problem Description
It was reported that, during machine set up for a navio-assisted surgery, it was found that six (6) navio bone pins 4.0mmx152mm had lost the threadings.No delays were reported.It is unknown how the procedure was completed.Patient outcome is unknown.
Additional Manufacturer Narrative
H3, h6: the six (6) navio bone pins, pn rob00031, lot # tu57762-02, intended for use in treatment, were returned for evaluation.A relationship between the reported event and the devices was established.The reported problem was visually confirmed.There is damage to the threads.The most likely cause of this event is product mishandling; external forces and/or pressure applied to the pin.Care and caution should be exercised during the surgical site setup, surgery and tear down to protect the device from an unforeseen force, such as falling onto a hard surface or damage.Refer to the navio surgical system user¿s manual for proper handling.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.A historical escalation event 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 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.Internal complaint reference: (b)(4).

• 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: 12203367
• Report Number: 3010266064-2021-00559
• Device Sequence Number: 11623362
• Product Code: OLO
• UDI-Device Identifier: 00885556685310
• UDI-Public: 00885556685310
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K170360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/15/2022

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
• Operator of Device: Health Professional
• Device Model Number: ROB00031
• Device Catalogue Number: ROB00031
• Device Lot Number: TU57762-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/09/2021
• Supplement Date Received by Manufacturer: 10/11/2021; 07/15/2022
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 10/12/2021; 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NAVIO SURGICAL SYSTEM INDIA: ROB00036, SN004165
• Patient Sex: Unknown