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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET TRAUMA ALPS CALIBRATED DRILL 2.7X160MM BIT, DRILL

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BIOMET TRAUMA ALPS CALIBRATED DRILL 2.7X160MM BIT, DRILL Back to Search Results
Catalog Number 214227160
Device Problems Difficult to Insert; Mechanical Jam
Event Date 02/10/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Concomitant medical products: catalog number 110008317 lot number 210790 - alps mis locking drill guide 2. 7mm. Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2017-01644 / 01645).

 
Event Description

It was reported that during a plating procedure, after drilling, the drill got stuck in the locking drill guide. No adverse events have been reported as a result of the malfunction. The doctor removed the drill from the guide with pliers.

 
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Brand NameALPS CALIBRATED DRILL 2.7X160MM
Type of DeviceBIT, DRILL
Manufacturer (Section D)
BIOMET TRAUMA
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw , IN 46582
5745273773
MDR Report Key6409088
Report Number0001825034-2017-01645
Device Sequence Number1
Product CodeHTW
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/21/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/16/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue Number214227160
Device LOT Number089220
OTHER Device ID NumberSEE H10
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/05/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/21/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/18/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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