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 separated during a procedure.It was confirmed that nothing fell into the surgical site.The procedure was completed successfully with no patient or user injuries, and no adverse consequences.

Manufacturer Narrative

Discarded by user facility.

• Brand Name: COAXIAL HIGH FLOW TIP
• Type of Device: LAVAGE, JET
• 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 0061 5
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 3760753
• MDR Text Key: 16087894
• Report Number: 0001811755-2014-01391
• 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 Health Care Professional
• Type of Report: Initial
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2014
• Initial Date FDA Received: 04/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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