MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY TIMESH STRAIGHT PLATE 1H X 1H 12MM; PLATE, BONE

Catalog Number	015-044
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Only the straight plate shaft was returned.One of the eyelets of the straight plate shaft was observed to be fractured open and distorted.It is unknown how or when the damage occurred.There was proteinaceous debris observed on the eyelet of the shaft.The instructions for use that accompany the device state that disassembly, bending, or breakage of any or all timesh components can occur.A review of the manufacturing records showed no anomalies.
Event or Problem Description
It was reported to medtronic neurosurgery that the plate broke prior to surgery.According to the report, the product was replaced with a new one to complete the procedure and the patient was well.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: TIMESH STRAIGHT PLATE 1H X 1H 12MM
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6179624
• Report Number: 2021898-2016-00476
• Device Sequence Number: 16376111
• Product Code: JEY
• UDI-Device Identifier: 00673978002682
• UDI-Public: 00673978002682
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K973145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2016

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 Catalogue Number: 015-044
• Device Lot Number: TV55183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Initial Date Received by Manufacturer: 11/16/2016
• Supplement Date Received by Manufacturer: 11/16/2016
• Initial Report FDA Received Date: 12/15/2016
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 77