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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

Additional mdr's 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; 3025141-2018-00206: case 6; 3025141-2018-00211: case 7; 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 and a screw.The locking screw of the fibular nail was removed (after fracture had united) because of soft tissue irritation.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: 7527735
• MDR Text Key: 108732075
• Report Number: 3025141-2018-00212
• 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