MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 11CM IQ APEX KNIFE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	550025B114
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that during a procedure, the tip broke, fragments needed to be removed from the patient, all fragments successfully removed.It was also reported that during the removal of the fragments, there was a two hour delay, and the patient required additional anesthesia to be administered.It was further reported that the procedure was completed successfully, without any medical intervention reported.
Event or Problem Description
It was reported that during a procedure, the tip broke, fragments needed to be removed from the patient, all fragments successfully removed.It was also reported that during the removal of the fragments, there was a two-hour delay, and the patient required additional anesthesia to be administered.It was further reported that the procedure was completed successfully, without any medical intervention reported.
Additional Manufacturer Narrative
D4: correction, added full udi.H6: the quality investigation is complete.

• Brand Name: 11CM IQ APEX KNIFE
• 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: kelsey barla ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 19883715
• Report Number: 3015967359-2024-01643
• Device Sequence Number: 11798605
• Product Code: LFL
• UDI-Device Identifier: 07613327422498
• UDI-Public: (01)07613327422498(17)260201(10)24037027
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2024

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 Catalogue Number: 550025B114
• Device Lot Number: 24037027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/04/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 08/01/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown