MAUDE Adverse Event Report: WARSAW ORTHOPEDICS UCSS SCREW SET

Catalog Number G873H136

Device Problems Use of Device Problem (1670); Malposition of Device (2616)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/25/2020

Event Type  Injury  

Manufacturer Narrative

This part is not approved for use in the united states; however a like device catalog #: 873-136, 510k #: k003928 and udi #: (b)(4) was cleared in the united states.Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the r eported event.X-ray review results: a post-op image for an odontoid screw/c2 fixation is provided.The bottom of the screw extends out of the c2 body a little bit and image quality makes it difficult to see the apposition of the dens to vertebral body.By report, the surgical technique was incorrect, no hardware failure was identified.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient presented with odontoid process fracture; and underwent a surgery at c2 using nakanishi method.Intra-op, in order to determine the screw length, when an attempt was made to measure with a depth gauge, it was noticed that the engraved position of the guide wire was wrong.This revealed that the guide wire was inserted in the opposite direction.The direction of inserting guide wire was wrong, and the blunt side without the thread was inserted to the vertebra body.The surgeon managed to determine the screw length with the guide wire as it was and the screw was placed.However, screw insertion was not at the position that the surgeon expected.Moreover, bone fragment was pushed by wrong use of the surgeon, and the fracture line deviated.Although no patient complications were reported, there is a possibility of considering a re-operation due to the imperfection of reduction.The procedure was delayed by less than 60 minutes as a result of this event.

• Brand Name: UCSS SCREW SET
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 9989736
• MDR Text Key: 189243745
• Report Number: 1030489-2020-00471
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: G873H136
• Device Lot Number: 0640075W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2020
• Initial Date FDA Received: 04/23/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/16/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention