MAUDE Adverse Event Report: XTANT MEDICAL SPIDER CERVICAL PLATING SYSTEM; SCREWDRIVER ASSEMBLY

Model Number	N60000160
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The company received notification on 8/20/2020 of an instrument malfunction that occurred during a surgical procedure.It was reported that the distal tip of a system screwdriver fractured while a system screw was rotated.The fractured portion of the complaint instrument was removed from the surgical site, and the procedure was successfully completed.There were no known patient complications associated with this product complaint.A visual assessment of the returned screwdriver showed an instrument with repeated use, as identified by worn laser markings, surface scratches, and wear to the tin coating.A small portion of the distal tip of the driver was fractured and not present.A functionality assessment could not be performed due to the damaged condition of the returned complaint instrument.A dhr review was performed for the returned lot, and there were no manufacturing anomalies identified.The device met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 7/18/2016.The distal tip of the screwdriver could fracture if there were excessive torque applied to the instrument or if a lateral force was applied to the screwdriver while seated in a system screw.If excessive torque was applied to the screwdriver, it may contribute to the distal tip fracturing from the body of the instrument.If a screwdriver had lateral force applied while seated in a system screw, it may concentrate forces to the interface between the driver and screw resulting in an instrument malfunction.
Event or Problem Description
The company received notification on 8/20/2020 of an instrument malfunction that occurred during a surgical procedure.It was reported that the distal tip of a system screwdriver fractured while a system screw was rotated.The fractured portion of the complaint instrument was removed from the surgical site, and the procedure was successfully completed.There were no known patient complications associated with this product complaint.

• Brand Name: SPIDER CERVICAL PLATING SYSTEM
• Common Device Name: SCREWDRIVER ASSEMBLY
• Manufacturer (Section D): XTANT MEDICAL; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 10541049
• Report Number: 3005031160-2020-00020
• Device Sequence Number: 13596149
• Product Code: HXX
• UDI-Device Identifier: M697N600001601
• UDI-Public: M697N600001601
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2020

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: N60000160
• Device Lot Number: 739601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 09/16/2020
• 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
• Patient Age: 42 YR
• Patient Weight: 61