MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 12CM IQ STANDARD; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	550025S307
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	10/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure that the vertebral artery was injured, there was no sudden drop in blood pressure and the anesthesiologist controlled and stabilized the blood pressure.Clipping and suturing were performed on the pinhole portion of the vertebral artery.After that, posterior fixation was concluded and the stratum corneum was closed.Postoperatively, the patient was managed in the icu.The procedure was completed successfully.
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.H3 other text : device not available for return.
Additional Manufacturer Narrative
H6: the quality investigation is complete.
Event or Problem Description
It was reported that during a procedure that the vertebral artery was injured, there was no sudden drop in blood pressure and the anesthesiologist controlled and stabilized the blood pressure.Clipping and suturing were performed on the pinhole portion of the vertebral artery.After that, posterior fixation was concluded and the stratum corneum was closed.Postoperatively, the patient was managed in the icu.The procedure was completed successfully.

• Brand Name: 12CM IQ STANDARD
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: colette chung ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 18181586
• Report Number: 3015967359-2023-02493
• Device Sequence Number: 20735928
• Product Code: LFL
• UDI-Device Identifier: 37613327422468
• UDI-Public: 37613327422468
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K190070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 550025S307
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2023
• Supplement Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female