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

Model Number	PFSDV0016
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, it was found that the tip of the navio bone pin 4.0 mm x 127 mm pin was cracked.The backup was used to continue the procedure without delays.There was no patient harm.
Additional Manufacturer Narrative
H3, h6: the navio bone pin, part pfsd01008 used for treatment was not made available to the designated complaint unit for evaluation thus, a visual and functional evaluation could not be performed.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.Although the reported problem was not confirmed, a contributing factor may be mechanical component failure.No containment or corrective actions are recommended at this time.If the product associated with this event is returned or provided 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: 10260426
• Report Number: 3010266064-2020-01647
• Device Sequence Number: 14223915
• Product Code: OLO
• UDI-Device Identifier: 00885556628904
• UDI-Public: 00885556628904
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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: PFSDV0016
• Device Catalogue Number: PFSD01008
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1