MAUDE Adverse Event Report: BIOMEDICAL ENTERPRISES, INC. ELITE 202013 "H" STAPLE; EL-202013H

Model Number EL-202013H

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/13/2016

Event Type  malfunction  

Event Description

Staple was inserted during routine cn procedure, six weeks post operative x-ray revealed that one leg of implant had broken.In mid (b)(6) of 2016, hardware was removed through explantation procedure.

• Brand Name: ELITE 202013 "H" STAPLE
• Type of Device: EL-202013H
• Manufacturer (Section D): BIOMEDICAL ENTERPRISES, INC.; 14785 omicron dr., suite 205; san antonio TX 78245
• Manufacturer Contact: joe soward ; 14785 omicron dr., suite 205; san antonio, TX 78245 ; 2108810011
• MDR Report Key: 5401752
• MDR Text Key: 37237834
• Report Number: 1649263-2016-00003
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/01/2020
• Device Model Number: EL-202013H
• Device Lot Number: BMEEL155191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 66