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U.S. Department of Health and Human Services

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

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ACUMED LLC ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
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.
 
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Type of DeviceROD, 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 Key7359576
MDR Text Key103129907
Report Number3025141-2018-00141
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K915613
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 03/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received03/07/2018
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 Treatment Data
Date Received: 03/21/2018 Patient Sequence Number: 1
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