MAUDE Adverse Event Report: ACUMED LLC; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

Additional mdrs associated with this article: 3025141-2020-00347: case 1, 3025141-2020-00349: case 3, 3025141-2020-00350: case 4.

Event Description

Article: safety and efficacy of surgical fixation of fibula fractures using an intramedullary nail: a retrospective observational cohort study in 30 patients; boni, guilherme; sanchez, gustavo t.; arliani, gustavo; zellle, boris a.; pires, robinson e; and dos reis, fernando b; patient safety in surgery (2019) 13:31.Case 2: patient experienced a new fracture in the area of the original fracture post op following implantation of a fibula nail.The nail was explanted and the fracture treatment was changed to a plate construct.

• 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: micki anderson ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 8886279957
• MDR Report Key: 10982734
• MDR Text Key: 220642122
• Report Number: 3025141-2020-00348
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2020
• 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 Number: 1
• Patient Outcome(s): Required Intervention