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

Model Number	PFSR101092
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported failure mode binding of the bone screw to the tissue protector is primarily due to tissue being wrapped around the threads.However, initial pin misalignment, bending of the screws, and misuse of the tissue protector can also be contributing factors.
Event or Problem Description
It was reported that during tka surgeon pushed tissue protector down into patients leg while drilling bone pin on tibia and after completing second bone pin drilling, the tissue protector got stuck.Attempted to pound and pry it off, but after several attempts, got it to budge and it came off.Bone pin broke at top while surgeon tried to pull out with drill.It is unknown the lenght of the surgical delay and no patient injuries were reported.

• 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
• MDR Report Key: 9706206
• Report Number: 3010266064-2020-00037
• Device Sequence Number: 19733746
• Product Code: OLO
• UDI-Device Identifier: 00885556628713
• UDI-Public: 00885556628713
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/12/2020

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: PFSR101092
• Device Catalogue Number: PFSR101092
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2017
• Initial Report FDA Received Date: 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1