MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) BIT 3MM-UC DRILL GUIDE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	960-524
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier field not sufficient to hold all digits, should read (b)(4).Return requested for suspect drill bit guide.No parts have been received by manufacturer for analysis.Part not received by manufacturer.
Event or Problem Description
A medtronic representative reported that, while in a pelvic fixation procedure, the site's drill bit guide was broken.This bit was connected to a non-medtronic drill.When pressing into the pelvis, the tip of the bit broke off inside the pelvic bone.The surgeon successfully removed the broken piece from the bone.The surgeon opted to continue the procedure using a non-navigated non-medtronic drill bit.Delay in therapy was less than one hour.There was no impact on patient outcome.

• Brand Name: BIT 3MM-UC DRILL GUIDE
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6055993
• Report Number: 1723170-2016-02690
• Device Sequence Number: 10770351
• Product Code: HAW
• UDI-Device Identifier: 00673978089966
• UDI-Public: 00673978089966
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K974161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: 960-524
• Device Lot Number: 130514
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2016
• Initial Report FDA Received Date: 10/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 92