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

Model Number	ROB00031
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a navio assisted surgery, when drilling the navio bone pin 4.0mmx152mm into the patient's femur, the surgeon appeared to struggle.He removed the pin to reposition and the pin was noticed to be bent.The surgeon used another pin to position the array and continue the surgery.The procedure was completed, with a non-significant delay, using a s+n back-up device.Patient was not harmed due to the problem reported.
Additional Manufacturer Narrative
Internal complaint reference case: (b)(4).
Additional Manufacturer Narrative
Section h10: the navio bone pin 4.0mmx152mm (uk), rob10031, 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.Although the reported problem was not confirmed, a factor that may have contributed to the reported symptom may be associated with the technique to insert and remove the bone pin.While all products meet required manufacturing specifications prior to release, a serial number, lot number, or part revision is required to link the device to a dhr or nc investigation.A complaint history review for similar reported/confirmed complaints found similar events.A historical escalation event review was not completed.The product was not returned and no evidence was made available to link the complaint to an escalation event.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.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.Internal complaint reference number: (b)(4).
Additional Manufacturer Narrative
H10: the navio bone pin 4.0mmx152mm (uk), rob10031, 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.Although the reported problem was not confirmed, a factor that may have contributed to the reported symptom may be associated with the technique to insert and remove the bone pin.The provided product identification information (part number, s/n, lot) did not match any known release of this part and thus a manufacturing record review could not be conducted.A complaint history review for similar reported/confirmed complaints found similar events.A historical escalation event review was not completed.The product was not returned and no evidence was made available to link the complaint to an escalation event.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.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.Internal complaint reference number: (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: 13716164
• Report Number: 3010266064-2022-00183
• Device Sequence Number: 6476758
• Product Code: OLO
• UDI-Device Identifier: 00885556685310
• UDI-Public: 00885556685310
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K191223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2022
• Supplement Date Received by Manufacturer: 07/25/2022; 09/10/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 08/09/2022; 09/12/2022
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROB00049-SN (B)(6)
• Patient Sex: Unknown