MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC GUIDE, SURGICAL, INSTRUMENT

Catalog Number	873-004
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient was pre-operatively diagnosed with odontoid process fractures and underwent anterior screw fixation surgery.During surgery, the guide wire broke.The product came in contact with the patient.There was a delay of less than 60 mins in procedure time as a result of the event.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: visual and optical inspection confirmed about an inch of the guidewire has been broken off.Optical inspection of the fracture surface confirmed a brittle surface with multiple ridges and some circular material flow.This type of damage is consistent with torsional overload causing the tip to break off.If information is provided in the future, a supplemental report will be issued.

• Brand Name: GUIDE, SURGICAL, INSTRUMENT
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 8109618
• Report Number: 1030489-2018-01570
• Device Sequence Number: 13536704
• Product Code: FZX
• UDI-Device Identifier: 00673978067681
• UDI-Public: 00673978067681
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2019

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: 873-004
• Device Lot Number: KH17F259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 20 YR