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

Model Number KM166-10-01

Device Problem Missing Value Reason (3192)

Patient Problem No Consequences Or Impact To Patient (2199)

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.

• Brand Name: BRASSELER USA TWIST DRILL
• Type of Device: SURGICAL 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 Key: 5624333
• MDR Text Key: 44174198
• Report Number: 2025102-2016-00003
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• 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

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KM166-10-01
• Device Catalogue Number: 5004057M0
• Device Lot Number: NG9FE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/14/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 117