MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN NAIL; NAIL, FIXATION BONE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Skin Irritation (2076)

Event Type  Injury  

Event Description

Information was received based on review of a journal article titled, "elastic intramedullary nailing and dbm-bone marrow injection for the treatment of simple bone cysts" which aimed to describe the technique and present the results of demineralized bone matrix (dbm), and autologous bone marrow injection in addition to intramedullary cannulation and stabilization for the treatment of large and active simple bone cysts using the win flexible nails manufactured at (b)(4).The study consisted of 9 patients with large active long bone cysts, 6 patients with proximal humerus cysts and 3 with proximal femur cysts.All patients were treated with thin trocar used to perforate bone cortex and aspirate cyst.Bone marrow/dbm mixture was injected into the cyst.Six weeks post op, all patients were pain free and had full range of motion.The only complication was irritation at nail entry site.The conclusion was elastic intramedullary nailing has the two-fold benefits of continuous cyst decompression, and early immediate stability to the involved bone segment, which permits early mobilization and return to the normal activities of the pre-teen patients.

Manufacturer Narrative

Current information is insufficient to permit conclusions as to the cause of the events.Event details and product identification was not provided for the patients mentioned in the journal article.Initial reporter - the article was written by kanellopoulos, a.Et al; world journal of surgical oncology 2007, 5: i i i doi: 10.1186/1477-7819-5-111.This article is available from: http://www.Wjso.Com/content/5/1/111.It is likely that these complications have already been reported; however, it cannot be determined based on the limited information made available in the article.Should additional information relating to the events be received, the updated information will be forwarded to the fda.

• Brand Name: UNKNOWN NAIL
• Type of Device: NAIL, FIXATION BONE
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4476410
• MDR Text Key: 5498250
• Report Number: 0001825034-2015-00423
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2015
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention