MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION SEASPINE SPINOUS PROCESS SYSTEM; T15 DRIVER

Model Number	95-3000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 95-3000 t15 driver was not returned for investigation, nor were any photos of the complaint unit received.Review of the device history record concluded the instrument is approximately 4.5 years old.The root cause cannot be determined as the driver was not provided for evaluation.Additionally, no photos of the complaint unit were received.Based on prior complaints related to driver fractures, analyses suggest the tip failure is the result of field damage or age/wear, including but not limited to repeat use, reprocessing, or excessive torsional force.The respective driver is a reusable instrument that is subject to handling and multiple sterilization cycles after distribution into the field.Wear and damage can occur over time.
Event or Problem Description
It was reported on (b)(6) 2022 that a screwdriver tip fractured intraoperatively on (b)(6) 2022 and was left inside the implant in the patient.

• Brand Name: SEASPINE SPINOUS PROCESS SYSTEM
• Common Device Name: T15 DRIVER
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer Contact: audrey mudderman ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 14946910
• Report Number: 3012120772-2022-00023
• Device Sequence Number: 17266640
• Product Code: PEK
• UDI-Device Identifier: 10889981096151
• UDI-Public: 10889981096151
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K173334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2022

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: 95-3000
• Device Catalogue Number: 95-3000
• Device Lot Number: AT17J006A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2017
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown