MAUDE Adverse Event Report: ACUMED, LLC 3.6MM X 170MM ULNA NAIL 2; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 4011-3617N-S

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/28/2021

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for evaluation.Manufacturing and inspection records were reviewed, and no anomalies were noted.

Event Description

During the procedure, fracture of the distal ulna occurred with drill placement for tiploc.There was no significant delay in procedure; however, this issue caused a need for another operation/procedure.This report is related to report number 3025141-2022-00060 which is on the tiploc bushing and screw set.

• Brand Name: 3.6MM X 170MM ULNA NAIL 2
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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 ; 5035209618
• MDR Report Key: 13775611
• MDR Text Key: 287248571
• Report Number: 3025141-2022-00061
• 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
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4011-3617N-S
• Device Catalogue Number: 4011-3617N-S
• Device Lot Number: 505676
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2022
• Initial Date FDA Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Ethnicity: Hispanic