MAUDE Adverse Event Report: Stryker Instruments-a division of Stryker Corp 11G x 15MM OMNICURVE FRACTURE KIT; Arthroscope

Catalog Number	1032-115-000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/13/2026
Type of Reportable Event	Malfunction

• Brand Name: 11G x 15MM OMNICURVE FRACTURE 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 ; +1(269)323-7700
• MDR Report Key: 50226034
• Report Number: 3015967359-2026-00456
• Device Sequence Number: 18733237
• Product Code: HRX
• UDI-Device Identifier: 07613327554496
• UDI-Public: (01)07613327554496
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K162062
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1032-115-000
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 08/12/2026
• 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
• Patient Sex: Unknown