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

Model Number	T066-0093
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that a drill bit was broken while preparing a path to introduce the screw for the spacer.There were no reported patient complications.A visual assessment of the broke drill bit confirmed that the fluting of the drill bit was broken as described by the complainant.A dhr review was performed and there were no manufacturing anomalies identified.The device met all required specifications prior to initial release to distribution.A drill bit could be broken if it had a lateral force applied.There are two techniques for implanting the associated implants.The technique that utilizes the straight drill also uses a guided inserter assembly.The guided inserter assembly has a hallow shaft to direct appropriate placement for screw hole preparation and screw insertion.If the drill was shifted while engaged within the guided inserter, it may break the drill bit.
Event or Problem Description
The complainant reported that a drill bit was broken while preparing a path to introduce the screw for the spacer.There were no reported patient complications.

• 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: 8761273
• Report Number: 3005031160-2019-00034
• Device Sequence Number: 2039806
• Product Code: HTW
• UDI-Device Identifier: M697T06600931
• UDI-Public: M697T06600931
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: T066-0093
• Device Lot Number: 45079-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2019
• 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: 72 YR
• Patient Weight: 79