MAUDE Adverse Event Report: BIOMEDICAL ENTERPRISES, INC. HAMMERLOCK 2 DRILL BIT; HTY, PIN, FIXATION, SMOOTH, 21 CFR 888.3040

Model Number DK H2

Device Problem Use of Device Problem (1670)

Patient Problem No Code Available (3191)

Event Date 01/29/2015

Event Type  Injury  

Event Description

Patient is a (b)(6) year old female who underwent hammertoe corrections of her second and third toes.The surgeon initially drilled the 3rd toe with the hl2 drill bit.However, during the course of drilling the proximal phalange shattered.The surgeon did not put an implant into the 3rd toe but tied it back together with curage wire.Next, the surgeon drilled and measured the 2nd toe and then he broached the 2nd toe but could only get the broach approximately 80-90 percent inserted into the bone.The surgeon then attempted to put in a medium hl2 implant but it would not go all the way in.So then he tried using a small hl2 implant but had a difficult time reducing the joint as there was still gaping at the joint.The surgeon removed the implant and used another means to finish the surgery.

• Brand Name: HAMMERLOCK 2 DRILL BIT
• Type of Device: HTY, PIN, FIXATION, SMOOTH, 21 CFR 888.3040
• 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: 4531340
• MDR Text Key: 16556368
• Report Number: 1649263-2015-00003
• 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: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 10/01/2019
• Device Model Number: DK H2
• Device Catalogue Number: DK H2
• Device Lot Number: BMEDK145135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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
• Patient Age: 29 YR