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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES ANSPACH EMAX 2 PLUS HAND PIECE - ROHS; K191223
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BLUE BELT TECHNOLOGIES ANSPACH EMAX 2 PLUS HAND PIECE - ROHS; K191223 Back to Search Results
Catalog Number PFSR101209
Device Problem Overheating of Device (1437)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/28/2021
Event Type  malfunction  
Event Description
It was reported that during a navio assisted tka surgery, the anspach emax 2 plus hand piece rohs had an e6 error during femoral burring.They removed the drill from the handpiece to let it cool and they were able to continue in under a minute.During tibial burring they got a second e6 error.They let it cool again and were able to finish the procedure with a minimal delay (fewer than 30 minutes) using same device.No patient injuries and no other complications were reported.
 
Manufacturer Narrative
H3, h6: the navio drill, part number 101209, s/n (b)(6) , used in treatment was returned for evaluation.A relationship between the reported event and the device was not confirmed.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.Although the reported problem was not confirmed, a factor that may have contributed to the reported symptom may have been associated with inadequate irrigation of the device.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.
 
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Brand Name
ANSPACH EMAX 2 PLUS HAND PIECE - ROHS
Type of Device
K191223
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
MDR Report Key11992460
MDR Text Key255983490
Report Number3010266064-2021-00446
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 07/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberPFSR101209
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2021
Date Manufacturer Received07/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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