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

Model Number	HLXS
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/16/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned to bme.
Event or Problem 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
• Common Device Name: HTY, PIN, FIXATION, SMOOTH
• Manufacturer (Section D): BIOMEDICAL ENTERPRISES, INC.; 14785 omicron dr., suite 205; san antonio TX 78023
• MDR Report Key: 5868420
• Report Number: 1649263-2016-00034
• Device Sequence Number: 482170
• Product Code: HTY
• UDI-Device Identifier: 00810633020067
• UDI-Public: 00810633020067
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K091951
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: HLXS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2013
• Initial Report FDA Received Date: 08/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention