MAUDE Adverse Event Report: BIOMEDICAL ENT., INC. HAMMERLOCK; HTY PIN, FIXATION, SMOOTH, 21 CFR 888.3040

Model Number HLXM

Device Problem Premature Activation (1484)

Patient Problem No Code Available (3191)

Event Date 09/04/2014

Event Type  Injury  

Event Description

On 10/28/2014, bme received information from dr.(b)(6) to conclude complaint investigation opened on (b)(6) 2014.He provided the following details.The case involved an arthrodesis of the third hammertoe (can't recall which foot).He prepared and reamed the ends per instructions.The proximal end was inserted without event.However, when he removed the hammerlock (x-type medium) distal prong cover, it had already deployed.Per dr.(b)(6), sales representative advised him to depress the distal prongs with a clamp to close.The prongs would not depress completely, he forced the distal end insertion and in process, fractured the lateral interior cortex.Upon this, he removed the implant and fixed site with kwire.He states the implant was stored appropriately.The patient experienced no delay in procedure and recovered without issue.

Manufacturer Narrative

• Brand Name: HAMMERLOCK
• Type of Device: HTY PIN, FIXATION, SMOOTH, 21 CFR 888.3040
• Manufacturer (Section D): BIOMEDICAL ENT., INC.; 14785 omicron dr., suite 205; san antonio TX 78245
• Manufacturer Contact: joe soward ; 14785 omicron dr., suite 205; san antonio, TX 78245 ; 2108810043
• MDR Report Key: 4466379
• MDR Text Key: 5180751
• Report Number: 1649263-2014-00004
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131640
• 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: 10/31/2014

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 Expiration Date: 12/01/2018
• Device Model Number: HLXM
• Device Catalogue Number: HLXM
• Device Lot Number: BMEHL135099C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/05/2014
• Initial Date FDA Received: 11/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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