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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES GUIDE, CUTTING, DISTAL, LARGE ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES GUIDE, CUTTING, DISTAL, LARGE ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number ROB101397
Device Problems Difficult to Remove (1528); Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/05/2016
Event Type  malfunction  
Event Description
It was reported that prior to a case, the tka large distal cutting guide screw was stuck and looked stripped. It could not be used. A backup device was available to be used during the procedure. No surgical delay or patient injury reported.
 
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Brand NameGUIDE, CUTTING, DISTAL, LARGE
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth, mn
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth, mn
Manufacturer Contact
richard confer
2828 liberty ave
suite 100
pittsburgh, pa 
6833844
MDR Report Key9989221
MDR Text Key188655371
Report Number3010266064-2020-00281
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberROB101397
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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