MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 20CM IQ APEX 360; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	550025B302
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/10/2023
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Per medwatch report mw5147031: it was reported that during a procedure the sonopet tip broke off and fell into the recess of the sphenoid sinus and was unable to be retrieved.The procedure was completed successfully without a clinically significant delay.The patient was seen the following week in the ent office and when packing was removed from the site, the tip was easily suctioned out once she was in an upright position.
Event or Problem Description
Per medwatch report mw5147031: it was reported that during a procedure the sonopet tip broke off and fell into the recess of the sphenoid sinus and was unable to be retrieved.The procedure was completed successfully without a clinically significant delay.The patient was seen the following week in the ent office and when packing was removed from the site, the tip was easily suctioned out once she was in an upright position.
Additional Manufacturer Narrative
H6: the quality investigation is complete.

• Brand Name: 20CM IQ APEX 360
• 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: 18220150
• Report Number: 3015967359-2023-02515
• Device Sequence Number: 17543410
• Product Code: LFL
• UDI-Device Identifier: 37613327422529
• UDI-Public: 37613327422529
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K213824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2024
• Device Catalogue Number: 550025B302
• Device Lot Number: 22299047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2023
• Supplement Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2022
• 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 Sex: Unknown