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	12/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the part of the device from the omni curve became stuck and inside the vertebral body.When the physician attempted to remove it, the part broke off.The patient had had a follow up with an orthopedic doctor to remove the piece outside of the vertebral body.This follow up was successful.It should be noted the after the follow up procedure, the patient is doing fine and is pain free.
Event or Problem Description
It was reported that the part of the device from the omni curve became stuck and inside the vertebral body.When the physician attempted to remove it, the part broke off.The patient had a follow up with an orthopedic doctor to remove the piece outside of the vertebral body.This follow up was successful.It should be noted the after the follow up procedure, the patient is doing fine and is pain free.
Additional Manufacturer Narrative
The device was not made accessible for testing; therefore, a root cause could not be determined for the event.

• 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: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 18520367
• Report Number: 3015967359-2024-00083
• Device Sequence Number: 12705936
• Product Code: HRX
• UDI-Device Identifier: 07613327554496
• UDI-Public: 07613327554496
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162062
• 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): 05/22/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1032-115-000
• Device Lot Number: 9185395
• 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: 12/22/2023
• Supplement Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 05/22/2024
• 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
• Patient Sex: Unknown