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

Device Problem Device Inoperable (1663)

Patient Problems Death (1802); Myocardial Infarction (1969)

Event Type  malfunction  

Manufacturer Narrative

Additional mdrs associated with this article: 3025141-2018-00202: case 2, 3025141-2018-00203: case 3, 3025141-2018-00204: case 4, 3025141-2018-00205: case 5, 3025141-2018-00206: case 6, 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 fibula fracture was treated with a fibular nail. Significant failure of fixation with the fibular nail occurred with shortening of the fibula and lateral subluxation of the talus. No revision surgery as the patient died from a myocardial infarction shortly after surgery (death unrelated to the acumed product). 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: 7527720
• MDR Text Key: 109012220
• Report Number: 3025141-2018-00201
• 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

• Type of Report: Initial
• Report Date: 05/08/2018

1 Device was Involved in the Event

0 Patients were 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

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• 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