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

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.

• Brand Name: AEQUALIS HUMERAL NAIL
• Type of Device: ROD, 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 Key: 11613084
• MDR Text Key: 243738391
• Report Number: 3004983210-2021-00020
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K082754
• Number of Events Reported: 1
• 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 Received: 04/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 0020600
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/09/2021
• 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