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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRASSELER U.S.A. MEDICAL, LLC BRASSELER USA TWIST DRILL SURGICAL TWIST DRILL

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BRASSELER U.S.A. MEDICAL, LLC BRASSELER USA TWIST DRILL SURGICAL TWIST DRILL Back to Search Results
Model Number KM166-10-01
Device Problem Missing Value Reason
Event Date 02/22/2016
Event Type  Malfunction  
Manufacturer Narrative

Device not returned.

 
Event Description

From customer: drill broke. From medwatch report (b)(4): "event desc: drill bit broke inside of patient's knee. A plier was used to remove the drill bit tip. This was matched by the scrub nurse to the rest of the metal and seemed to be a matching fit. What was the original intended procedure? repair quadriceps tendon device usage problem: device failed (e. G. Broke, couldn't get it to work or stopped working).

 
Manufacturer Narrative

The manufactured lot ng6qd dhr was reviewed and identified to be manufactured within specifications with no anomalies found. If the drill was not properly held straight when chucked in the collet, if any excessive, bending, or lateral forces are used, if the drill came into contact with any metal objects during use, and if the drill may have been inadvertently bent during preparation, these scenarios among others may contribute to the drill bending during use. With the information provided and with the preparation methods and surgical techniques unknown a specific cause cannot be determined. Device not returned.

 
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Brand NameBRASSELER USA TWIST DRILL
Type of DeviceSURGICAL TWIST DRILL
Manufacturer (Section D)
BRASSELER U.S.A. MEDICAL, LLC
4837 mcgrath st
ventura CA 93003
Manufacturer (Section G)
BRASSELER U.S.A. MEDICAL, LLC
4837 mcgrath st
ventura CA 93003
Manufacturer Contact
kenneth jones
4837 mcgrath st
ventura , CA 93003
9129217501
MDR Report Key5624333
Report Number2025102-2016-00003
Device Sequence Number1
Product CodeHTY
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 03/23/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/02/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberKM166-10-01
Device Catalogue Number5004057M0
Device LOT NumberNG9FE
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 Received02/23/2016
Was Device Evaluated By Manufacturer? No
Date Device Manufactured08/14/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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