MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP FOOTED ATTACHMENT 16MM; DRILLING POWER TOOL ATTACHMENT, BASIC

Catalog Number	5407FA2000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Dural Tear (1417)
Date of Event	06/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During a craniotomy at the user facility, the dura was torn.Additional surgery was required to mend the dura, and the procedure was completed successfully.

• Brand Name: FOOTED ATTACHMENT 16MM
• Common Device Name: DRILLING POWER TOOL ATTACHMENT, BASIC
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 25712877
• Report Number: 3015967359-2026-00440
• Device Sequence Number: 17428536
• Product Code: HBE
• UDI-Device Identifier: 07613327096392
• UDI-Public: (01)07613327096392
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K191049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/05/2026

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: 5407FA2000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 07/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown