MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO HANDPIECE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number PFSR110137

Device Problem Mechanical Jam (2983)

Patient Problem No Patient Involvement (2645)

Event Date 12/06/2016

Event Type  malfunction  

Event Description

It was reported that, during an unspecified surgery, the handpiece / drill failed homing several times.Unsnapping the probe and snapping it back on was tried, but the drill itself was not moving when trying to home.It was checked that the drill was properly locked into the handpiece, and it was.The case was exited and a handpiece test was performed twice: both times the torque was 84.When went back into the case, the drill would not retract all the way.Homing was tried once more, but the drill still did not move.A new handpiece / drill homed as expected.Surgery was delayed a few minutes.The patient was not involved at the time, as this happened when the equipment was set-up.

Manufacturer Narrative

H3, h6: the device, used in treatment, was returned for evaluation.It was reported that the handpiece / drill failed homing several times during a case.The initial visual/functional investigation found that: the visual inspection revealed a bent drill guide support.Dhr review found that no conditions that could contribute to the reported event were found.The reported product met manufacturing specifications prior to being released for distribution.A complaint history review found similar reports.The probable cause of the issue was a mechanical component failure.A relationship between the device and the reported event could be established.Visual and functional inspection of the handpiece confirmed that the drill guide support on the handpiece was bent, which was causing the reported homing difficulties.

• Brand Name: NAVIO HANDPIECE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9989219
• MDR Text Key: 188672367
• Report Number: 3010266064-2020-00328
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/03/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: PFSR110137
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: 07/27/2020
• Supplement Dates FDA Received: 08/03/2020
• Patient Sequence Number: 1
• Treatment: 101209 - ANSPACH EMAX 2 PLUS HAND PIECE - ROHS; 101209 - ANSPACH EMAX 2 PLUS HAND PIECE - ROHS