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	12/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.F 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 anterior cervical fixation at c2.Intra-op, when the guide wire was being inserted through the guide from the anterior side, the tip broke and got stuck inside the bone.The second guide wire was continued to be inserted.The guide wire that had been stuck inside the bone was removed after drilling and then screw was inserted.There was a delay of less than 60 minutes in overall procedure time as a result of this event.No broken fragments of the guide wire remained inside the patient.No patient complications were reported.

• 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: 9571254
• Report Number: 1030489-2020-00046
• Device Sequence Number: 492226
• 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
• Report Date (Section B): 01/09/2020

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: KH17M380
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 01/09/2020
• 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