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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES RI ROBOTIC DRILL ATTACHMENT ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES RI ROBOTIC DRILL ATTACHMENT ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number ROB10015
Device Problems Break (1069); Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/17/2022
Event Type  malfunction  
Event Description
It was reported that after a cori assisted tka surgery, they noticed that plastic on the ri robotic drill attachment tip (the wiper) was broken. Also, the metal ring rotates inside the attachment, which should be normally firmly anchored. Since the issue occurred after procedure, patient was not longer involved.
 
Manufacturer Narrative
Internal complaint reference case(b)(4).
 
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Brand NameRI ROBOTIC DRILL ATTACHMENT
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key14069033
MDR Text Key288987286
Report Number3010266064-2022-00272
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
008855567573
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/09/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROB10015
Device Catalogue NumberROB10015
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/17/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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