MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. XPRESS MINIMALLY INVASIVE PEDICLE SCREW SYSTEM; PEDICLE SCREW SPINAL SYSTEM

Model Number	N60000473
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual assessment of the returned complaint ratcheting screwdriver handle showed and instrument with repeated use, as identified by surface scratches and worn laser markings.The proximal impact cap was fractured from the handle body as reported.A functionality assessment was not performed due to the damaged condition of the instrument, which was removed from distributable inventory.A dhr review was performed for the complaint lot and there were no manufacturing anomalies identified.The device lot met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 3/20/2014.The proximal impact cap of the ratcheting screwdriver handle is a t-shaped plug that is secured into the end of the instrument, surrounded by a silicone handle.An excessive force impact to the edge of the impact cap can cause the cap to flex on the silicone handle and result in a fractured impact cap.The root cause of this complaint is an excessive force impact to the edge of the proximal impact capthere have not been any other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor this instrument for complaints from the field.
Event or Problem Description
The manufacturer received notification on 9/29/2022 of a system ratcheting screwdriver handle that malfunctioned during a surgical procedure.It was reported that the proximal impact cap of the handle fractured when impacted.There were no known patient complications associated with this complaint.The procedure was successfully completed with an alternate available instrument.A replacement instrument was provided to the complainant and a return authorization was issued for return of the complaint instrument, which was received at the manufacturer on 10/03/2022 for complaint assessment.

• Brand Name: XPRESS MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer (Section G): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer Contact: rebecca lennemann ; 664 cruiser lane; belgrade, MT 59714
• MDR Report Key: 15620913
• Report Number: 3005031160-2022-00028
• Device Sequence Number: 6471084
• Product Code: MNI
• UDI-Device Identifier: M697N600004731
• UDI-Public: M697N600004731
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K152132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2022

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: 53164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown