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

Model Number	T080-0070
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 9667945
• Report Number: 3005031160-2020-00003
• Device Sequence Number: 19563856
• Product Code: OVD
• UDI-Device Identifier: M697T08000701
• UDI-Public: M697T08000701
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K133947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2020

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: T080-0070
• Device Lot Number: 595101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 02/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR