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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER INC AEQUALIS HUMERAL NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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TORNIER INC AEQUALIS HUMERAL NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 0020600
Device Problem Patient-Device Incompatibility (2682)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/28/2021
Event Type  Injury  
Manufacturer Narrative
Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
 
Event Description
Allegedly, it was reported via medwatch report mw5099185 the patient had a proximal humerus fracture in 2020 that was fixed using a humeral nail and 3 proximal 5. 0 interlocking screw and 2 distal 4. 3mm interlocking screws. The nail, had cut out laterally resulting in a revision surgery where the surgeon removed the nail and inserted a fibular strut graft and locking proximal humerus plate.
 
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Brand NameAEQUALIS HUMERAL NAIL
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
TORNIER INC
10801 nesbitt avenue s
bloomington MN 55437
Manufacturer (Section G)
TORNIER INC
10801 nesbitt avenue s
bloomington MN 55437
Manufacturer Contact
andrew melchiori
1023 cherry rd
memphis, TN 38117
MDR Report Key11613084
MDR Text Key243738391
Report Number3004983210-2021-00020
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K082754
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial
Report Date 03/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0020600
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/05/2021 Patient Sequence Number: 1
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