MAUDE Adverse Event Report: BIOTEX MEDICAL BA-320-185; BONE ANCHOR

Device Problems Break (1069); Material Fragmentation (1261); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/28/2014

Event Type  malfunction  

Event Description

Following completion of procedure, it was discovered during anchor bolt removal that the anchor bolt was broken.The break was at the point of attachment of threads.The surgeon opted to leave in the small plastic threads in place rather than remove.

• Brand Name: BA-320-185
• Type of Device: BONE ANCHOR
• Manufacturer (Section D): BIOTEX MEDICAL; houston TX 77054
• Manufacturer Contact: 8058 el rio; houston, TX 77054 ; 7137410111
• MDR Report Key: 4102325
• MDR Text Key: 4720587
• Report Number: 3005726841-2014-00007
• Device Sequence Number: 1
• Product Code: HOA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/27/2014

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/28/2014
• Initial Date FDA Received: 08/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1