MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 20CM IQ APEX 360; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	550025B302
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a surgical procedure, it was noted that the tip of the device broke in the patient.It was further reported that the procedure was completed successfully.No further information was provided.
Additional Manufacturer Narrative
A follow-up report will be filed once the quality investigation is complete.Awaiting for device return to manufacturer.
Event or Problem Description
It was reported that during a surgical procedure, it was noted that the tip of the device broke in the patient.It was also reported that a fragment of the tip of the device remained in the patient which requires an additional surgery to remove the fragment.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
B1 & b2; adverse event/product problem changed to medical intervention and required intervention to prevent permanent impairment/damage (devices) b5; updated executive summary following confirmation of medical intervention for additional surgery to remove tip fragment.H6: a follow up report will be filed once the quality investigation is complete.H3 other text : awaiting for device return to manufacturer.
Event or Problem Description
It was reported that during a surgical procedure, it was noted that the tip of the device broke in the patient.It was also reported that a fragment of the tip of the device remained in the patient which requires an additional surgery to remove the fragment.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
The quality investigation is complete.

• Brand Name: 20CM IQ APEX 360
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 16134704
• Report Number: 0001811755-2023-00006
• Device Sequence Number: 7524421
• Product Code: LFL
• UDI-Device Identifier: 37613327422529
• UDI-Public: 37613327422529
• Combination Product (Y/N): N
• Initial Reporter State: VI
• Initial Reporter Country: AS
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2023

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: 550025B302
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2022
• Supplement Date Received by Manufacturer: 12/15/2022; 07/21/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 01/12/2023; 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Other; Required Intervention
• Patient Sex: Unknown