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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 03/09/2017
Event Type  malfunction  
Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.
 
Event Description
We opened 2x 7020140 drill bits during the case and both had perforations through the sterile packaging.The patient impact was that we had to wait for 30mins while the drill bit was getting processed, this was while the patient was anesthetised.So additional anesthetic time and procedure time.
 
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Brand Name
AEQUALIS HUMERAL NAIL SYSTEM
Type of Device
DRILL 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 Key7289199
MDR Text Key100921962
Report Number3004983210-2018-00004
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
K082754
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Remedial Action Recall
Type of Report Initial
Report Date 02/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Catalogue Number7020140
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/21/2018
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 Sequence Number1
Patient Outcome(s) Required Intervention;
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