MAUDE Adverse Event Report: ACUMED LLC 2.6MM X 270MM FIBULA NAIL 2; ROD, FIXATION, INTRAMEDULLARY

Model Number 4010-2627N-S

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2022

Event Type  malfunction  

Event Description

During the procedure when using the fibula nail 2, the entire surgical technique was followed for both the distal portion of the fibula, as well as the tip-loc as well.However, the tip-loc mechanism wouldn't allow the fibula 2 nail to go through the hole to connect together as one.Many different options were tried on attempting to get the devices to work as the technique called for however; it didn't work.The surgeon had to drop the tourniquet time, wait, and then use another company product with plates and screws instead of the fibula nail 2 device.Follow up was conducted and responses received indicated this was not a threading issue.The fibula nail 2 would not go through the eyelet of the tip-loc bushing properly, which lead to the inability to utilize the tip-loc technology mechanism.The delay in procedure was a 1 hour delay for the fibula nail 2 issue, but overall led to roughly a 3 hour delay including the plate and screw revision/salvage part of the case where the surgeon had to utilize another company's product since the tip-loc wouldn't work properly.

Manufacturer Narrative

The results of the investigation were inconclusive because the device was not returned for evaluation.Manufacturing and inspection records were reviewed, and no anomalies were found.The issue will continued to be monitored via trending.

Manufacturer Narrative

Field h5 in 3025141-2022-00033 initial report, labeled for single use was inadvertently checked /selected as "no".This field was intended to be blank (have no response selected).

• Brand Name: 2.6MM X 270MM FIBULA NAIL 2
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: ellie wood ; 5885 ne cornelius pass road; hillsboro, OR 97124
• MDR Report Key: 13519062
• MDR Text Key: 286492822
• Report Number: 3025141-2022-00033
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4010-2627N-S
• Device Catalogue Number: 4010-2627N-S
• Device Lot Number: 511070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 86 KG