MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. SPIDER CERVICAL PLATING SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	N60000160
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was made aware of a product complaint on (b)(6)2023.It was reported that the distal hex tip of a system screwdriver fractured during a surgical procedure.There were no known patient complications or delay in treatment associated with this complaint.An alternate available instrument was used to successfully complete the procedure.An rma# was issued for return of the complaint screwdriver, which was received at the manufacturer for assessment on (b)(6)2023.
Additional Manufacturer Narrative
A visual assessment of the returned system screwdriver showed an instrument with repeated use, as identified by surface scratches and worn tin coating.The distal hex tip was broken as reported.A functionality assessment was not performed due to the damaged condition of the returned system screwdriver, which was removed from distributable inventory.A dhr review was performed for the instrument lot and there were no manufacturing anomalies identified.The instrument lot met all required specifications prior to being released to distributable inventory.The system screwdriver lot has been available for distribution since 7/18/2016.The system surgical technique guide provides guidance on preparation of patient bone for implantation of system screws, including a statement that includes, "in cases where there is unusually hard bone present, drilling can be performed." the complainant reported that the screwdriver malfunction occurred when the surgeon was having difficulty advancing a system screw into hard bone.The patient bone had not been drilled in preparation for implantation of the system screws, and when the system screwdriver was rotated the distal hex tip fractured from the instrument.The surgeon then drilled the patient bone to prepare for system screw implantation, which was completed without incident.There has been one other complaint of similar nature in the past 12 months.The manufacturer will continue to monitor this instrument for complaints from the field.

• Brand Name: SPIDER CERVICAL PLATING SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade MT
• Manufacturer (Section G): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade
• Manufacturer Contact: rebecca lennemann ; 664 cruiser lane; belgrade
• MDR Report Key: 17071517
• Report Number: 3005031160-2023-00010
• Device Sequence Number: 20304931
• Product Code: HXX
• UDI-Device Identifier: M697N600001601
• UDI-Public: M697N600001601
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K170224
• 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): 06/06/2023

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: N60000160
• Device Lot Number: 739601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2016
• 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
• Patient Age: 60 YR
• Patient Sex: Unknown