MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 11G IVAS ACCESS CANNULA; CEMENT, BONE, VERTEBROPLASTY

Catalog Number 0306330000

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/11/2022

Event Type  malfunction  

Event Description

Per the customer, the outer part of the access cannula popped off the hub of the needle.The doctor was reported to be exposed to the patient's blood during the event.Additional information has been requested from the user facility.

Manufacturer Narrative

Device evaluation: follow-up report submitted to document the device evaluation.

Event Description

Per the customer, the outer part of the access cannula popped off the hub of the needle.The doctor was reported to be exposed to the patient's blood during the event.The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.

• Brand Name: 11G IVAS ACCESS CANNULA
• Type of Device: CEMENT, BONE, 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 ; * 00615
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 13757068
• MDR Text Key: 287124096
• Report Number: 3015967359-2022-00491
• Device Sequence Number: 1
• Product Code: OAR
• UDI-Device Identifier: 37613252505991
• UDI-Public: 37613252505991
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/21/2023

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
• Device Catalogue Number: 0306330000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/14/2022
• Initial Date FDA Received: 03/14/2022
• Supplement Dates Manufacturer Received: 02/20/2023
• Supplement Dates FDA Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1