MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC SPIDER CERVICAL PLATING SYSTEM; SCREWDRIVER

Model Number	N60000160
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient underwent an initial anterior cervical discectomy and fusion procedure.During the procedure, it was reported that a mallet was used to tap the screw forward, which resulted in the fracturing of the distal tip of the screwdriver.No pieces were retained by the patient.No patient complications were reported.No additional information available.
Additional Manufacturer Narrative
The reported event was able to be confirmed via a visual assessment.The visual assessment showed an instrument with surface scratches and the distal tip was broken as reported.A functionality assessment was unable to be performed due to the damaged condition of the 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 and utilized a mallet to tap the screw forward.There has been zero other complaints 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: SCREWDRIVER
• Manufacturer (Section D): XTANT MEDICAL HOLDINGS, INC; 664 cruiser ln; belgrade 59714
• Manufacturer (Section G): XTANT MEDICAL HOLDINGS, INC; 664 cruiser ln; belgrade MT 59714
• Manufacturer Contact: rebecca lennemann ; 664 cruiser ln; belgrade, MT 59714 ; 4069245878
• MDR Report Key: 20695888
• Report Number: 3005031160-2024-00038
• Device Sequence Number: 6583669
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/15/2024

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: 10/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 11/15/2024
• 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 Sex: Male