MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK SCREWDRIVER - HEX THREADED

Catalog Number	7756195
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/22/2018
Type of Reportable Event	Serious Injury
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Pre-operative diagnosis: cervical spondylotic myelopathy due to symptomatic recurrence.Type of procedure: posterior cervical decompression and fusion with dural suture.It was reported that intra-operatively when the pedical screw was inserted in c7 through ct navigation it was observed with the help of c-arm that it was penetrating the end plate of cranial side at c7 and deviated from pedical screw.Due to which the screw driver slid and touched the dura and injury of the dura occurred.Thereafter additional surgery dural suture was performed, so the screw was removed.While inserting the screw after decompression.A crack occurred in the arch of vertebra.Due to which the screw was not inserted.The surgery was delayed by less than 60 minute due to this event.Both the implants did not come in contact with the patient.No breakage of implants occurred due to reported event.No fragments of instruments were remained in patient.Patient complications were unknown with the available information.The tip of the driver did not fit with the screw and slipped due to which dura injured and dural suture was performed.

• Brand Name: SCREWDRIVER - HEX THREADED
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• MDR Report Key: 7624947
• Report Number: 1030489-2018-00888
• Device Sequence Number: 1317450
• Product Code: HXX
• UDI-Device Identifier: 00613994207999
• UDI-Public: 00613994207999
• 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
• Report Date (Section B): 06/21/2018

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: 7756195
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 06/21/2018
• 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: Other
• Patient Age: 78 YR