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

Model Number HLXS

Device Problem Device Operational Issue (2914)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/16/2013

Event Type  Injury  

Manufacturer Narrative

Device not returned to bme.

Event Description

Patient underwent hammertoe correction procedure on (b)(6) 2013, during insertion, implant leg expanded and cracked the cortical wall.The device was removed and k-wire used for final fixation.If additional information pertinent to this incident is obtained, a supplemental report will be submitted.

• Brand Name: HAMMERLOCK
• Type of Device: HTY, PIN, FIXATION, SMOOTH
• Manufacturer (Section D): BIOMEDICAL ENTERPRISES, INC.; 14785 omicron dr., suite 205; san antonio TX 78023
• Manufacturer Contact: joe soward ; 14785 omicron dr., suite 205; san antonio, TX 78245 ; 2108810043
• MDR Report Key: 5868420
• MDR Text Key: 51846675
• Report Number: 1649263-2016-00034
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00810633020067
• UDI-Public: 00810633020067
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/02/2016

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: Health Professional
• Device Model Number: HLXS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/16/2013
• Initial Date FDA Received: 08/11/2016
• Was Device Evaluated by Manufacturer?: No
• 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