MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 12CM IQ MICRO CLAW; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	550025B315
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	12/07/2022
Type of Reportable Event	Serious Injury
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 cranial procedure, the tip of the device damaged the patients dura.It was also reported that there was an unintentional dural opening as a result of this event.It was further reported the patients dura required to be sutured.It was also reported that the procedure was completed successfully.
Event or Problem Description
It was reported that during a cranial procedure, the tip of the device damaged the patients dura.It was also reported that there was an unintentional dural opening as a result of this event.It was further reported the patients dura required to be sutured.It was also reported that the procedure was completed successfully.
Additional Manufacturer Narrative
H6: the quality investigation is complete.H3 other text : product status unknown.

• Brand Name: 12CM IQ MICRO CLAW
• 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: 16070980
• Report Number: 0001811755-2022-00074
• Device Sequence Number: 6262448
• Product Code: LFL
• UDI-Device Identifier: 37613327422383
• UDI-Public: 37613327422383
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/05/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 550025B315
• 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: 12/07/2022
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 09/05/2023
• 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: Other; Required Intervention
• Patient Sex: Unknown