MAUDE Adverse Event Report: Stryker Instruments-a division of Stryker Corp 11g iVAS Access Cannula; Injector, vertebroplasty

Catalog Number	0306330000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the cannula broke inside the the patient, the case was stopped and the canula was removed the following day.

• Brand Name: 11g iVAS Access Cannula
• Common Device Name: Injector, vertebroplasty
• Manufacturer (Section D): Stryker Instruments-a division of Stryker Corp; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): Stryker Instruments-Puerto Rico; las palmas industrial park; highway #3, km 130.2; arroyo 00615 ; PR 00615
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; +1(269)323-7700
• MDR Report Key: 50411877
• Report Number: 3015967359-2026-00465
• Device Sequence Number: 15746324
• Product Code: OAR
• UDI-Device Identifier: 07613252505990
• UDI-Public: (01)07613252505990(17)281101(10)25317012
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2026

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: 0306330000
• Device Lot Number: 25317012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2026
• 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: Required Intervention
• Patient Sex: Unknown