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

Device Problems Break (1069); Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913)

Patient Problems Inflammation (1932); Pain (1994); Rupture (2208)

Event Type  Injury  

Event Description

Per attached article, an acumed im forearm rod was implanted in a (b)(6) male after his arm was caught in a conveyor belt.Nineteen months later an attempt was made to remove the implant, it failed because the threaded portion of the nail remover was broken while being connected to the nail.Two years after the failed surgery, the patient visited with complaints of occurrence of left elbow pain, without having any new trauma.A partial defect of the triceps tendon with severe pain and tenderness around the scar of nail insertion was noted.No other abnormalities were observed.Ultrasonography revealed partial rupture of the triceps tendon, and bursitis around the tender area.Based on these observations, the nail was removed and repair of the tendon was done.Reference: new technique for removal of the ulnar intramedullary nail failed to remove: broken assembly piece in the nail.Jin woong yi, byung hak oh, sang-bum kim, youn moo heo, tae gyun kim, doo hyun kim, you sun jung.Clinics in orthopedic surgery.2016; 8:210-213.

• 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: 7359576
• MDR Text Key: 103129907
• Report Number: 3025141-2018-00141
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915613
• 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: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/07/2018
• Initial Date FDA Received: 03/21/2018
• 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
• Patient Age: 39 YR