MAUDE Adverse Event Report: VILEX, INC. TITANEX; TITANEX T6 DRIVER

Model Number	ZT702-06-09
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(4) 2018, vilex received call from account manager that a titanex driver twisted during surgery.Issue review form was sent and completed by account manager.Account manager stated the doctor was using the titanex ii set for a bunion.Doctor chose a 2.0mm screw and began to driving the screw into the bone with the driver (zt702-06-09).The tip of the driver began to twist.Doctor changed to a second driver and after completing on turn, he noticed a slight twist.On 03/06/2018, vilex received the drivers.On 03/13/2018, vilex qc department examined the drivers and found nothing visually wrong with the drivers to cause the tips to twist.Qc department determined that they may have encountered hard bone.On 03/21/2018, vilex spoke with the doctor involved.Doctor stated that the patient was young with very hard bone.And he probably should have drilled prior to driving the screw.On 03/27/2018, vilex sent one of the drivers in question to an unrelated supplier, who has experience in drivers and material, to review.On 03/27/2018, vilex sent one of the drivers in question to the subcontracted manufacturer for review.Vilex will file an updated report once information/evaluation has been obtained from the two suppliers mentioned above.
Event or Problem Description
Doctor was using titanex driver (zt702-06-09) to insert a 2.0mm screw.As he began to drive the screw, the driver tip twisted.Doctor changed to the second driver.He began to drive the screw and after making one turn, doctor noticed slight twist in the tip of the driver.

• Brand Name: TITANEX
• Common Device Name: TITANEX T6 DRIVER
• Manufacturer (Section D): VILEX, INC.; 111 moffitt street; mcminnville TN 37110
• MDR Report Key: 7379816
• Report Number: 1051526-2018-00002
• Device Sequence Number: 1092680
• Product Code: HWC
• UDI-Device Identifier: 00841731116253
• UDI-Public: 00841731116253
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/28/2018

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 Model Number: ZT702-06-09
• Device Catalogue Number: ZT702-06-09
• Device Lot Number: 7928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2015
• Initial Report FDA Received Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1