MAUDE Adverse Event Report: STRYKER-SPINE YUKON OCT SPINAL SYSTEM; SPINAL FIXATION SYSTEM, PRODUCT

Catalog Number 7601-05030

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 11/19/2018

Event Type  Injury  

Manufacturer Narrative

Stryker completed its acquisition of k2m, inc.(k2m) on (b)(6) 2018.As part of integration activities stryker spine performed a retrospective review of k2m post market surveillance complaints or the period 2017 to 2018.The purpose of this review was to assess reportability decisions and ensure consistency with the stryker corporate procedures and policies.As a result of that review, this mdr (malfunction) is being filed.The device was visually and microscopically inspected.The screw housing was engaged to the inserter tip upon receipt.Upon review, it was observed that the screw had fractured immediately below the ball feature of the screw shank.Analysis of the fracture face indicated that the failure likely occurred in torsion.Manufacturing and inspection records of the subject lot were reviewed and no relevant discrepancies were found.

Event Description

A physician reported that the shaft of a yukon polyaxial screw broke during implant surgery.The broken device was removed and replaced with a 15 minute surgical delay.Surgery was completed with a back-up device.There was no consequence to the patient.

• Brand Name: YUKON OCT SPINAL SYSTEM
• Type of Device: SPINAL FIXATION SYSTEM, PRODUCT
• Manufacturer (Section D): STRYKER-SPINE; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): STRYKER-SPINE; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: margarita karan ; 2 pearl court; allendale, NJ 07401
• MDR Report Key: 8977600
• MDR Text Key: 161338587
• Report Number: 3004774118-2019-01078
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 10888857350021
• UDI-Public: 10888857350021
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7601-05030
• Device Lot Number: FUWW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Date Manufacturer Received: 11/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1