MAUDE Adverse Event Report: BIOMEDICAL ENTERPRISES, INC. HAMMERLOCK 2; PIN, FIXATION, SMOOTH

Model Number HL2MA

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 11/16/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015, patient underwent a hammertoe correction surgery.During insertion, the distal leg poked through the cortex on the fourth toe.The surgeon didn't have any concerns regarding patient outcome or recovery.The device was not explanted.

• Brand Name: HAMMERLOCK 2
• Type of Device: PIN, FIXATION, SMOOTH
• 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: 5312376
• MDR Text Key: 33935421
• Report Number: 1649263-2015-00011
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133520
• 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: 12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/01/2020
• Device Model Number: HL2MA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/18/2015
• Initial Date FDA Received: 12/18/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/19/2015
• 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: 50 YR
• Patient Weight: 68