MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO BONE PIN 4.0MM X 127MM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	PFSD01008
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a tka surgery, the bone screw was noticed as bent and wobbly.A back-up device was available to complete the procedure.Surgery was delayed less than 30 min.The patient was not harmed.
Additional Manufacturer Narrative
H10: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional evaluation could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review identified prior similar events.This failure mode will be trended to assess for any necessary corrective actions.Factors that could have contributed to the reported event include the user allowing the weight of the drill to fall as it is attached to the pin, if the bone pin is held rigidly in place during removal, or if the patient¿s bone is harder than normal.A relationship, if any, between the subject device and the reported event could not be determined.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 4.0MM X 127MM
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10000391
• Report Number: 3010266064-2020-01539
• Device Sequence Number: 2208572
• Product Code: OLO
• UDI-Device Identifier: 00885556628737
• UDI-Public: 00885556628737
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2020

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: PFSD01008
• Device Catalogue Number: PFSD01008
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/24/2019
• Initial Date Received by Manufacturer: 10/17/2019
• Supplement Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 04/27/2020
• Supplement Report FDA Received Date: 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1