MAUDE Adverse Event Report: XTANT MEDICAL IRIX-A LUMBAR INTEGRATED FUSION SYSTEM; RATCHETING SCREWDRIVER HANDLE

Model Number	N60000473
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The company received notification on (b)(6) 2020 for a system handle in which the proximal cap fractured from the body of the instrument while the surgeon was striking it with the mallet.There were no known patient complications associated with this complaint.A visual assessment of the returned handle showed an instrument with repeated use, as identified by worn laser markings and surface scratches.The proximal cap of the returned handle was fractured from the body of the instrument and not returned.The proximal cap of the system handle is a t-shaped plug that is secured into the end of the handle, surrounded by a silicone handle.An impact to the edge of the cap may cause the cap to flex on the silicone handle and result in a fractured cap.The condition of the proximal cap could not be confirmed due to it not being returned for complaint assessment.The complaint investigation suggests the possibility that the edge of the cap was impacted, resulting in an instrument malfunction.
Event or Problem Description
The company received notification on (b)(6) 2020 for a system handle in which the proximal cap fractured from the body of the instrument, while the surgeon was striking it with the mallet.There were no known patient complications associated with this complaint.

• Brand Name: IRIX-A LUMBAR INTEGRATED FUSION SYSTEM
• Common Device Name: RATCHETING SCREWDRIVER HANDLE
• Manufacturer (Section D): XTANT MEDICAL; 664 cruiser lane; belgrade, mt
• MDR Report Key: 10482761
• Report Number: 3005031160-2020-00019
• Device Sequence Number: 3394960
• Product Code: HXX
• UDI-Device Identifier: M697N600004731
• UDI-Public: M697N600004731
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171567
• 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): 09/02/2020

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: N60000473
• Device Lot Number: 76836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 09/02/2020
• 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