MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO SOFT TISSUE PROTECTOR; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	PFSR101092
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tibial bone pin got stuck in prong of tissue protector.Could not remove with mallet and it was removed with another pin driver.Delay of less than 30 minutes reported and no injuries involved.
Additional Manufacturer Narrative
Correction: b1, b2 and h1 were updated to report type adverse event.

• Brand Name: NAVIO SOFT TISSUE PROTECTOR
• 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: rick confer ; 2828 liberty ave; suite 100; pittsburgh, PA 38116 ; 4126833844
• MDR Report Key: 9234518
• Report Number: 3010266064-2019-00122
• Device Sequence Number: 2233251
• Product Code: OLO
• UDI-Device Identifier: 00885556628713
• UDI-Public: 00885556628713
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/15/2022

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: PFSR101092
• Device Catalogue Number: PFSR101092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 09/27/2019; 07/01/2021; 10/06/2022; 11/08/2022
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 02/23/2020; 07/01/2021; 10/07/2022; 11/15/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1634-2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ORNPFS02000
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown