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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

Additional mdrs associated with this article: 3025141-2018-00231: case 1; 3025141-2018-00233: case 2.

Event Description

Patient with a fracture of the fibula was treated with a fibula rod and screws.The patient had subluxation of the ankle joint posteriorly, after a tri-malleloar fracture was fixed with a nail.The posterior fracture was initially held with 2 small fragment cancellous screws.Revision of the fixation was undertaken using a posterior plate on the tibia in addition to a posterior fibula plate.The patient developed a lateral infection and again lost fixation, eventually requiring an ankle fusion.The patient had significant comorbidities preoperatively, including chronic steroid use.Reference: appleton, p et al., the fibula nail for treatment of ankle fractures in elderly and high risk patients.Techniques in foot and ankle surgery 5(3):204-208, 2006.

• 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 lehman ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 8886279957
• MDR Report Key: 7527785
• MDR Text Key: 108732134
• Report Number: 3025141-2018-00235
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/08/2018
• 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