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

Model Number	HL2L
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/27/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned to bme.
Event or Problem Description
Patient underwent hammertoe correction procedure on (b)(6) 2015.At 3 weeks post operative, x-ray revealed that implant had broken.Patient has not required revision surgery, nor removal of broken implant.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: 5548914
• Report Number: 1649263-2016-00021
• Device Sequence Number: 16242658
• Product Code: HTY
• UDI-Device Identifier: 00810633021446
• UDI-Public: 00810633021446
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K133520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2019
• Device Model Number: HL2L
• Was Device Available for Evaluation?: No
• Device Age: 2 YR
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2015
• Initial Report FDA Received Date: 04/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 82