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

Model Number 9001640

Device Problem Naturally Worn (2988)

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

Event Date 01/26/2021

Event Type  malfunction  

Manufacturer Narrative

The returned times screws had signs of damage on the head of the screw.This may be he potential cause for slippage observed in the field.It is unknown how this damage may have occurred.The ifu cautions, "all products should be treated with care.Improper use or handling may lead to damage and possible improper functioning of the device.Before and after each cleaning, inspect each device for signs of damage or wear.Excessive wear of the driver blades may lead to insufficient engagement of the screw." if information is provided in the future, a supplemental report will be issued.

Event Description

Information was received regarding a patient undergoing skull repair surgery.It was reported that the device slipped and could not be used.As a result the screw was replaced and the procedure completed successfully.Additional information received reported that the cause of the screw becoming stripped was because of the screw cap.

• 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
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer Contact: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 11406229
• MDR Text Key: 234507364
• Report Number: 2021898-2021-00051
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00613994106810
• UDI-Public: 00613994106810
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K974017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• 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: T208361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2018
• 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 Age: 37 YR