MAUDE Adverse Event Report: XENCO MEDICAL LLC XENCO MEDICAL; T-25 DRIVER 1/4 SQUARE

Model Number	XM-115-0025
Medical Device Problem Codes	Mechanical Problem (1384); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During surgery, three screw drivers were broken during the final tightening during pedicle screw surgery.The broken driver tips remained within the set screws and were retrieved.Surgery was delayed one hour to remove the broken driver tips.There was no injury to the patient.Additional correspondence with the sales rep identified the following events: the first screw was successfully torqued.When torquing the second screw, the shaft broke at the top of the cap, flush with the surface of the cap but with material lodged inside the cap.Another two shafts broke with the debris lodged in the cap.The sales rep who was at the surgery suspects that it was the torque handle that failed.Per the sales rep, the torque limiting driver clicked on the first screw but did not click with any of the additional shafts.

• Brand Name: XENCO MEDICAL
• Common Device Name: T-25 DRIVER 1/4 SQUARE
• Manufacturer (Section D): XENCO MEDICAL LLC; 9930 mesa rim road; san diego 92121 2910
• MDR Report Key: 8672592
• Report Number: 3011181154-2019-00001
• Device Sequence Number: 2353638
• Product Code: HXX
• UDI-Device Identifier: B064XM11500251
• UDI-Public: B064XM11500251
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/29/2019

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: XM-115-0025
• Device Catalogue Number: XM-115-0025
• Device Lot Number: 170620; 170678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 06/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR