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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CANCELLOUS BIT 3MM UC DRIL NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC CANCELLOUS BIT 3MM UC DRIL NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 960-527
Device Problems Material Integrity Problem (2978); Device Handling Problem (3265)
Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/21/2021
Event Type  malfunction  
Manufacturer Narrative
No parts have been returned to the manufacturer for analysis. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation device being used for an orthopedic trauma procedure. It was reported that the tip of the 2. 1 drill broke off in the patient while drilling in the sacroiliac region for a combination luminous/open right hip replacement. The surgeon was unable to retrieve the drill bit tip, was aware it will remain retained, and proceeded with the procedure. The site only used navigation on these procedure for the universal drill guide to help gain the proper trajectory. It was noted that the site usually used a 960-524 3mm bit, but it had been dropped off the sterile field. The surgeon proceeded with the 960-527 3mm cancellous bit with a 2. 1mm tip (approximately 27mm). The length of that 2. 1 mm tip was what was retained in the patient. The surgeon stated that there was no impact on patient or procedure. There was no surgical delay and the instrument was discarded.
 
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Brand NameCANCELLOUS BIT 3MM UC DRIL
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11874167
MDR Text Key252312950
Report Number1723170-2021-01375
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K974161
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 05/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number960-527
Device Catalogue Number960-527
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/21/2021
Was Device Evaluated by Manufacturer? No
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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