MAUDE Adverse Event Report: TRILLIANT SURGICAL, LTD 2.0MM TIGER CANNULATED HEADLESS SCREW; SCREW, FIXATION, BONE

Catalog Number	202-20-018
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/10/2017
Type of Reportable Event	Malfunction
Event or Problem Description
During a 5th metatarsal fracture case on a (b)(6) female, the doctor experienced some bone splitting while inserting a 202-20-018 tiger headless cannulated screw.The doctor used a k-wire in this case, pre-drilled, and fully prox drilled before inserting any of the screws.One of the 202-20-018 screws went in without any issues.During insertion of the other 200-20-018 screw into the patient, and as the head of the screw was being inserted, the bone began to split.The split occurred near the outside of the bone and the split went across the bone requiring the doctor to remove a portion of bone from the patient.The doctor then used some bone putty in order to fill in the spot where the piece of bone was removed from the patient.The trilliant rep at the case did note that the doctor utilized a 2.4 mm prox drill in this case due to prior experience.The doctor thought that utilizing a larger prox drill would allow for more countersinking which could allow more room for the head of the screw.Both 202-20-018 screws remain in the patient and will not be removed while the 2.4 mm prox drill was billed for and tossed after the case.The 212-24-003 driver was kept by the sales representative to be used in other cases.

• Brand Name: 2.0MM TIGER CANNULATED HEADLESS SCREW
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): TRILLIANT SURGICAL, LTD; 6721 portwest drive; suite 160; houston TX 77024
• MDR Report Key: 7360403
• Report Number: 3007420745-2017-00005
• Device Sequence Number: 16722327
• Product Code: HWC
• UDI-Device Identifier: 00812926021539
• UDI-Public: 00812926021539
• Combination Product (Y/N): N
• PMA/510(K) Number: K112737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 04/28/2017

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
• Operator of Device: No Information
• Device Catalogue Number: 202-20-018
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/10/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2017
• Initial Report FDA Received Date: 03/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 68