MAUDE Adverse Event Report: BIOMEDICAL ENT., INC. HAMMERLOCK 1.1; PIN, FIXATION, SMOOTH, 21 CFR 888.3040

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

On (b)(6) 2015, a bme distributor received an x-ray from a sales rep which revealed a hammerlock 1.1 (model and size unavailable) inserted at an angle.One of the implant legs broke the cortical wall and was outside of the bone.As fusion had already taken place, the surgeon clipped off the protruding implant leg and did not explant the device.No further details are available at this time.

• Brand Name: HAMMERLOCK 1.1
• Type of Device: PIN, FIXATION, SMOOTH, 21 CFR 888.3040
• Manufacturer (Section D): BIOMEDICAL ENT., INC.; 14785 omicron dr.; ste 205; san antonio TX 78245
• Manufacturer Contact: joe soward ; 14785 omicron dr.; ste 205; san antonio, TX 78245 ; 2108810011
• MDR Report Key: 4663546
• MDR Text Key: 5685999
• Report Number: 1649263-2015-00004
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 04/03/2015

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: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/03/2015
• Initial Date FDA Received: 04/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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