MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES HANDPIECE, EMAX 2 PLUS (ANSPACH DRILL), ROHS COMPLIANT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number PFSR101209

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 11/03/2019

Event Type  malfunction  

Event Description

It was reported that during a demo case, e8 error on drill during drill test, then tried on different machine and e8 error again.Investigation results determined an internal wiring damage, which makes it a reportable event.

Manufacturer Narrative

H10 h3, h6: the device was intended to use in treatment and it was reported that the drill displayed e8 error during drill test.The drill was returned for investigation.Dhr review found that no conditions which could contribute to the reported event were identified.This information is reasonably suggesting that the device met the specifications at the date when it was released to the distribution.A complaint history found similar reports.We could confirm there was a relationship established between the reported event and the device.The device was returned for investigation.A drill test was performed and the drill showed to be spinning at 2000 rpm and there was an abnormal noise.Then, there was an e2 error on the console.The drill was unplugged and plugged back in.The console showed an e8 error and the drill would no spin.Then the drill was unplugged and plugged back in, and the lights on the console did not light up to indicate that a drill was plugged in.The drill was returned to the oem for service.The root cause after investigation was established to be supplier / raw material fault.

• Brand Name: HANDPIECE, EMAX 2 PLUS (ANSPACH DRILL), ROHS COMPLIANT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9997230
• MDR Text Key: 188905330
• Report Number: 3010266064-2020-00970
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K080802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PFSR101209
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1