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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Additional mdrs associated with this article: 3025141-2018-00201: case 1, 3025141-2018-00202: case 2, 3025141-2018-00203: case 3, 3025141-2018-00204: case 4, 3025141-2018-00205: case 5, 3025141-2018-00211: case 7, 3025141-2018-00212: case 8, 3025141-2018-00213: case 9, 3025141-2018-00214: case 10, 3025141-2018-00215: case 11, 3025141-2018-00216: case 12, 3025141-2018-00217: case 13, 3025141-2018-00220: case 14, 3025141-2018-00221: case 15, 3025141-2018-00222: case 16, 3025141-2018-00224: case 17, 3025141-2018-00225: case 18, 3025141-2018-00226: case 19, 3025141-2018-00227: case 20, 3025141-2018-00228: case 21.

Event Description

Patient with a fracture of the fibula was treated with a fibula rod.The construct failed but was not revised.Reference: bugler, k.E., et al., the treatment of unstable fractures of the ankle using the acumed fibular nail: development of a technique.J bone joint surg br, 2012.94(8): p.1107-12.

• 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: 7527733
• MDR Text Key: 109012443
• Report Number: 3025141-2018-00206
• 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?: No
• Is this a Product Problem Report?: Yes
• 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