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

Catalog Number	873-004
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/25/2020
Type of Reportable Event	Serious Injury
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 presented with odontoid process fracture; and underwent a surgery at c2 using (b)(6) method.Int ra-op, in order to determine the screw length, when an attempt was made to measure with a depth gauge, it was noticed that the engraved position of the guide wire was wrong.This revealed that the guide wire was inserted in the opposite direction.The direction of inserting guide wire was wrong, and the blunt side without the thread was inserted to the vertebra body.The surgeon managed to determine the screw length with the guide wire as it was and the screw was placed.However, screw insertion was not at the position that the surgeon expected.Moreover, bone fragment was pushed by wrong use of the surgeon, and the fracture line deviated.Although no patient complications were reported, there is a possibility of considering a re-operation due to the imperfection of reduction.The procedure was delayed by less than 60 minutes as a result of this event.
Additional Manufacturer Narrative
X-ray review results: a post-op image for an odontoid screw/c2 fixation is provided.The bottom of the screw extends out of the c2 body a little bit and image quality makes it difficult to see the apposition of the dens to vertebral body.By report, the surgical technique was incorrect, no hardware failure was identified.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: 9989521
• Report Number: 1030489-2020-00470
• Device Sequence Number: 19982769
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 873-004
• Device Lot Number: KH18C418
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2020
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 04/23/2020
• Supplement Report FDA Received Date: 04/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention