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	Numbness (2415)
Date of Event	02/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following the procedure, the patient is complaining of numbness from knee to feet.Patient is unable to stand upright nor walk.Per sales representative, there was no alleged device issue during procedure.
Event or Problem Description
After attempting to gather more information abut the follow reported, we were unable to determine if any of this was completed.Per sales representative, there was no alleged device issue during procedure.
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.

• 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: 21800040
• Report Number: 3015967359-2025-00600
• Device Sequence Number: 8249453
• Product Code: HRX
• UDI-Device Identifier: 07613327298611
• UDI-Public: (01)07613327298611
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/15/2025

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: 02/24/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 04/08/2025
• Supplement Report FDA Received Date: 08/15/2025
• 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: Required Intervention; Other
• Patient Sex: Unknown