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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER INC. AEQUALIS HUMERAL NAIL SYSTEM DRILL BIT

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TORNIER INC. AEQUALIS HUMERAL NAIL SYSTEM DRILL BIT Back to Search Results
Catalog Number 7020140
Device Problem Device Packaging Compromised (2916)
Patient Problem No Code Available (3191)
Event Date 02/22/2018
Event Type  malfunction  
Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.
 
Event Description
When opening four of the 7020140 drill bits during the case, all had perforations through the sterile packaging. The patient impact was that the patient had to be awakened and the surgery had to be completed the next day.
 
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Brand NameAEQUALIS HUMERAL NAIL SYSTEM
Type of DeviceDRILL BIT
Manufacturer (Section D)
TORNIER INC.
10801 nesbitt avenue south
bloomington MN 55437
Manufacturer Contact
matt kennedy
10801 nesbitt ave south
bloomington, MN 55437
9526837482
MDR Report Key7327154
MDR Text Key102105782
Report Number3004983210-2018-00010
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K082754
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 03/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7020140
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/09/2018 Patient Sequence Number: 1
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