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

Catalog Number	MDK-0001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Neuropathy (1983); Pain (1994); Atrophy (4913)
Date of Event	12/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Event was reported by patient via medwatch.The patient stated that during a mild procedure, the doctor removed old scar tissue from a previous two-level spinal fusion instead of the ligamentum flavum, which caused nerve issues.The patient alleged that the scar tissue removal led to permanent disablement and major muscle atrophy in every muscle that the s1 innervates.The patient stated this also caused cauda equina syndrome and arachnoiditis.Based on the information provided, there was no malfunction of the mild device.
Additional Manufacturer Narrative
Based on the event date in the medwatch form the event occurred prior to stryker¿s acquisition of the company.

• 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: 24904533
• Report Number: 3015967359-2026-00240
• Device Sequence Number: 18408862
• Product Code: HRX
• UDI-Device Identifier: 07613327651683
• UDI-Public: (01)07613327651683
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/16/2026

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: MDK-0001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/16/2026
• 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: Disability
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White