MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 11G/10MM IVAS SYSTEM KIT; CEMENT, BONE, VERTEBROPLASTY

Catalog Number 0705310000

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2017

Event Type  malfunction  

Event Description

It was reported that during a procedure at the user facility that upon removal of the device from the patient, that the handle came off and the cannula remained in the patient.The procedure was completed successfully after clamps were used to remove the cannula from the patient.No clinically significant delays and no additional adverse consequences to the patient were reported.

Manufacturer Narrative

Event Description

It was reported that during a procedure at the user facility that upon removal of the device from the patient, that the handle came off and the cannula remained in the patient.The procedure was completed successfully after clamps were used to remove the cannula from the patient.No clinically significant delays and no additional adverse consequences to the patient were reported.

• Brand Name: 11G/10MM IVAS SYSTEM KIT
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615
• Manufacturer Contact: zachary baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 6349922
• MDR Text Key: 68035935
• Report Number: 0001811755-2017-00663
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0705310000
• Device Lot Number: 16068012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2017
• 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
• Patient Outcome(s): Required Intervention