MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 11G IVAS ACCESS CANNULA; ARTHROSCOPE

Catalog Number	0306330000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the 11g access cannula bent and consequently broke while being removed from vertebral body.It should be noted that the procedure was completed successfully, with no patient impact, or medical intervention.There was a surgical delay of 2 hours to remove the broken device from the patient.
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.Full udi not available due to missing lot number.
Event or Problem Description
It was reported that the 11g access cannula bent and consequently broke while being removed from vertebral body.It should be noted that the procedure was completed successfully, with no patient impact, or medical intervention.There was a surgical delay of 2 hours to remove the broken device from the patient.

• Brand Name: 11G IVAS ACCESS CANNULA
• 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-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615 ; * 00615
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 20136898
• Report Number: 3015967359-2024-01768
• Device Sequence Number: 12616810
• Product Code: HRX
• UDI-Device Identifier: 07613252505990
• UDI-Public: (01)07613252505990
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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): 10/28/2024

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: 0306330000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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; Other
• Patient Sex: Unknown