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

Model Number 95-3000

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/26/2022

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 303730914
• Report Number: 3012120772-2022-00023
• Device Sequence Number: 1
• Product Code: PEK
• UDI-Device Identifier: 10889981096151
• UDI-Public: 10889981096151
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K173334
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 95-3000
• Device Catalogue Number: 95-3000
• Device Lot Number: AT17J006A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1