MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY TIMESH 6 X SCREWS, SELF-DRILLING (SDS), CRUCIATE; PLATE, FIXATION, BONE

Model Number 9001640

Device Problem Break (1069)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during the surgery, the screw slipped, the screw broke, and the connecting plate and titanium cap hole broke.This resulted in a procedure delay of 2 minutes.The procedure was completed with backup products.The patient's status at the time of the report was alive-no injury.Additional information received reported that this problem had been occurring since (b)(6) 2018; however, this was the first time the hospital had notified the distributor of the quality problems.It was noted that the titanium products need to be disinfected in the hospital supply room after unpacking, and then sent to the operating room.Similar products on the market may cause the product to break due to manual operation and other reasons during the disinfection process.This compensation mainly belonged to the obvious broken products picked out by the staff in the supply room during the disinfection or after the doctor opened the disinfection package in the operating room.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported that a disinfecting agent was not used as part of the disinfection process.The disinfecting process that was followed was clean water shower plus high temperature and high pressure disinfection.The process of putting loose screws into the box was operated by the workers responsible for the disinfection in the hospital.It was noted that the temperature was 134 degrees celsius, and the pressure was 3bar.

• Brand Name: TIMESH 6 X SCREWS, SELF-DRILLING (SDS), CRUCIATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• MDR Report Key: 10782113
• MDR Text Key: 214804053
• Report Number: 2021898-2020-00321
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 20613994106814
• UDI-Public: 20613994106814
• Combination Product (y/n): N
• PMA/PMN Number: K974017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9001640
• Device Catalogue Number: 9001640
• Device Lot Number: T165353
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1