MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. IRIX-A LUMBAR INTEGRATED FUSION SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number T080-0070

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2020

Event Type  malfunction  

Manufacturer Narrative

The complainant reported on (b)(6) 2020 that the distal tip of a system screwdriver fractured during an alif procedure on (b)(6) 2020.The broken portion of the instrument was removed from the surgical field and the procedure was successfully completed.There were no reported patient complications.A visual assessment of the returned complaint instrument showed an instrument with repeated use as identified by surface scratches and lightly worn laser markings.Approximately 0.2" of the distal tip of the instrument was sheared off.A functionality assessment could not be performed due to the condition of the returned instrument.A dhr review was performed for the complaint instrument lot and there were no manufacturing anomalies identified.The lot met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 3/17/16.It may be possible that the tip of a system screwdriver could fracture when placing an implant if the instrument was inadvertently shifted while engaged with a system screw, if excessive rotational pressure was applied, or if the instrument was being used at an angle.The system screwdriver is used while engaged with a ratcheting handle that does not limit applied torque.If the ratcheting handle attached to the system screwdriver was rotated more than required to adequately drive an implant screw, it may be possible that the distal tip of the instrument could fracture as observed.In the screw insertion section of the system surgical technique guide it states, "do not over tighten.A click may be heard as the screw passes the locking arm on the faceplate." it may be possible that the audible click of the implant locking arm was not perceived by the user, and the ratcheting handle attached to the system screwdriver was over tightened, resulting in an instrument malfunction.Using a system screwdriver at an angle can concentrate applied rotational force to a smaller area of engagement between the instrument and implant, which may result in an instrument malfunction.

Event Description

The complainant reported on (b)(6) 2020 that the distal tip of a system screwdriver was broken when being used during an alif procedure on (b)(6) 2020.The broken portion of the instrument was removed form the surgical field and the procedure was successfully completed.There were no reported patient complications.

• Brand Name: IRIX-A LUMBAR INTEGRATED FUSION SYSTEM
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer (Section G): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer Contact: casey ming ; 664 cruiser lane; belgrade, MT 59714 ; 4063880480
• MDR Report Key: 9667945
• MDR Text Key: 199715616
• Report Number: 3005031160-2020-00003
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: M697T08000701
• UDI-Public: M697T08000701
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: T080-0070
• Device Lot Number: 595101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2016
• 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 Outcome(s): Other
• Patient Age: 48 YR