MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP MILD DEVICE KIT; ARTHROSCOPE

Catalog Number	MDK-0001
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	03/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had an epidural hematoma the day after undergoing a mild procedure using the stryker device.The doctor stated the procedure went smoothly and the patient left without any reported issues.The patient informed the doctor that they wen to the er the following day with symptoms unknown and that is when the epidural hematoma was found.The patient will be taken for a decompression surgery.
Additional Manufacturer Narrative
We did not receive any further information from the customer on what occurred after the procedure.There were no allegations of any device malfunction by the customer either.
Event or Problem Description
After attempting to gather more information about the post procedure decompression surgery, we were unable to determine if this was completed.There was not allegations of any device malfunction by the customer.

• Brand Name: MILD DEVICE KIT
• Common Device Name: ARTHROSCOPE
• 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: 21721877
• Report Number: 3015967359-2025-00576
• Device Sequence Number: 3728422
• Product Code: HRX
• UDI-Device Identifier: 04546540434289
• UDI-Public: (01)04546540434289(17)271122(10)11597193
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2025

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: MDK-0001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 08/08/2025
• 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; Required Intervention
• Patient Sex: Unknown