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

Model Number	T066-0086
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that two drill bits bent upon removal after piloting holes during surgery.The instrument kits contained two drill bits and the surgery was successful with the two drill bits.There were no reported patient complications.The following mdrs are associated with this event: 3005031160-2019-00031.The drill bits have not been returned for complaint assessment.The complainant provided photos of the drill bits, both drill bits had misshaped flutes and were not straight.A dhr review was performed and there were no manufacturing anomalies identified.The devices met all required specifications prior to being released to distributable inventory.The fixed angle drill tips can become bent if lateral force is applied.Lateral force could be applied to the drill bits if they were inadvertently impacted or shifted while in-use.The complainant reported that the drill bits were discovered to be bent after drilling holes for screw placement.The guided inserter has a hollow shaft to direct appropriate placement for screw hole preparation and screw insertion.If the handle attached to the drill bit was shifted while the drill bit was still within the shaft of the guided inserter tip, it may bend the drill bits.
Event or Problem Description
The complainant reported that two drill bits bent upon removal after piloting holes during surgery.The instrument kits contained two drill bits and the surgery was successful with the two drill bits.There were no reported patient complications.The following mdrs are associated with this event: 3005031160-2019-00031.

• Brand Name: IRIX-C CERVICAL 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: 8761277
• Report Number: 3005031160-2019-00032
• Device Sequence Number: 11160760
• Product Code: HTW
• UDI-Device Identifier: M697T06600861
• UDI-Public: M697T06600861
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K131951
• 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): 07/03/2019

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: T066-0086
• Device Lot Number: 2372-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 07/03/2019
• 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: 38 YR