MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO COAXIAL HIGH FLOW TIP; LAVAGE, JET

Catalog Number 0210014100

Device Problem Disassembly (1168)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/24/2014

Event Type  malfunction  

Event Description

It was reported that the coaxial high flow tip fell apart during a procedure and into the surgical site.The tip was removed by hand and a back up device was used to complete the procedure successfully.There were no patient or user injuries, and no adverse consequences.

Manufacturer Narrative

The reported unit was not available to the manufacturer for evaluation, therefore, the claimed condition could not be confirmed.Not received for evaluation.

Event Description

It was reported that the coaxial high flow tip fell apart during a procedure and into the surgical site.The tip was removed by hand and a back up device was used to complete the procedure successfully.There were no patient or user injuries, and no adverse consequences.

Manufacturer Narrative

A follow up report will be filed after the device is received and the quality investigation has been completed.Device not yet received by manufacturer.

• Brand Name: COAXIAL HIGH FLOW TIP
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; highway #3, km 130.2; kalamazoo MI 49001 006
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 0061 5
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 3760693
• MDR Text Key: 16863747
• Report Number: 0001811755-2014-01389
• Device Sequence Number: 1
• Product Code: FQH
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/24/2014

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 Operator: Health Professional
• Device Catalogue Number: 0210014100
• Device Lot Number: 14038012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/25/2014
• Initial Date FDA Received: 04/21/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/11/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/07/2014
• 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