MAUDE Adverse Event Report: K2M. INC, A SUBSIDIARY OF STRYKER CORPORATION YUKON OCT SPINAL SYSTEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 7601-90138

Device Problems Device Issue (2379); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 02/27/2018

Event Type  malfunction  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The product was not returned to manufacturer for evaluation, and a thorough investigation could not be completed as the lot number has not been identified/confirmed in this case.Since the subject device was not returned, no physical, chemical evaluation could be performed, and the root cause of the reported issue could not be ascertained.

Event Description

On (b)(6) 2018 it was reported to k2m, inc.That a surgery took place in which an incorrect instrument was used to tighten the set screws.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The instrument was returned from the field.The handle was designed and manufactured with an ao connection.The torque limiting shaft, which is indicated to mate with the handle, was designed with a hexagonal connection.These connector styles are not cross-compatible.

Event Description

On (b)(6) 2018 it was reported to k2m, inc.That a surgery took place in which an incorrect instrument was used to tighten the set screws.

• Brand Name: YUKON OCT SPINAL SYSTEM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M. INC, A SUBSIDIARY OF STRYKER CORPORATION; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 7365048
• MDR Text Key: 103439274
• Report Number: 3004774118-2018-00031
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7601-90138
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 7601-10001 LOT GJFU; 7601-90092 LOT UNKNOWN