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

Model Number XM-115-0025

Device Problems Mechanical Problem (1384); Device Damaged by Another Device (2915)

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

Event Date 03/08/2019

Event Type  malfunction  

Event 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
• Type of Device: T-25 DRIVER 1/4 SQUARE
• Manufacturer (Section D): XENCO MEDICAL LLC; 9930 mesa rim road; san diego 92121 2910
• Manufacturer (Section G): XENCO MEDICAL; 9930 mesa rim road; san diego CA 92121 2910
• Manufacturer Contact: ryan woods ; 9930 mesa rim road; san diego, CA 92121-2910 ; 8582021505
• MDR Report Key: 8672592
• MDR Text Key: 147321521
• Report Number: 3011181154-2019-00001
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: B064XM11500251
• UDI-Public: B064XM11500251
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/08/2019
• Initial Date FDA Received: 06/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 62 YR