MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY TIMESH®; PLATE, FIXATION, BONE

Model Number	015-044
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient age not available from the site.Patient weight not available from the site.The screw holes of the plate were found to be broken.It was unknown how this damage occurred in the field.The instructions for use (ifu) cautions, "over-bending, notching, striking and scratching of the implants with any instrument should be avoided to reduce the risk of breakage." if information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a connection plate and screw.It was reported that when implanting the connected plate and fixed screw into the patient, the position of the screw hole was deformed with no force, and the site was forced to replace it with a new connected plate and 2 screws.There was no reported impact to the patient.Additional information was received stating that the screw holes were deformed prior to use.

• Brand Name: TIMESH®
• Common Device Name: 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 13933983
• Report Number: 2021898-2022-00080
• Device Sequence Number: 14635491
• Product Code: HRS
• UDI-Device Identifier: 00643169620292
• UDI-Public: 00643169620292
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K973145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 015-044
• Device Catalogue Number: 015-044
• Device Lot Number: T240156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female