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	03/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a piece of the balloon may have been left in the patient after it ruptured.The procedure was completed successfully without a clinically significant delay; no medical intervention or adverse consequences were reported.
Additional Manufacturer Narrative
Full udi is not available due to missing serial number.
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a root cause could not be determined for the event.
Event or Problem Description
No new information.

• 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 ; 2693237700
• MDR Report Key: 21710748
• Report Number: 3015967359-2025-00574
• Device Sequence Number: 4515190
• Product Code: HRX
• UDI-Device Identifier: 07613327554496
• UDI-Public: (01)07613327554496
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 09/15/2025

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 09/15/2025
• 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
• Patient Sex: Unknown