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

Model Number	PFSR101092
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/18/2016
Type of Reportable Event	Serious Injury
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 surgery the first bone pin was inserted in femur through the tissue protector and became stuck when doctor tried to remove the protector.Tried to back out the bone pin by reversing the drill and the head of the pin snapped off into the pin driver.This left the broken pin inside the tissue protector and pin still stuck in femur.It was noticed the pin would not turn within the protector and therefore the only way for doctor to remove the pin was to turn the entire tissue protector around enough times to unthread the pin manually from the femur.Delay of 30 minutes and no patient injuries reported.
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
• MDR Report Key: 9677451
• Report Number: 3010266064-2020-00031
• Device Sequence Number: 16844159
• Product Code: OLO
• UDI-Device Identifier: 00885556628713
• UDI-Public: 00885556628713
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2020

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: No Information
• Device Model Number: PFSR101092
• Device Catalogue Number: PFSR101092
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/18/2016
• Supplement Date Received by Manufacturer: 07/18/2016
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 02/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention