MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO INTERPULSE HANDPIECE WITH COAXIAL FAN SPRAY TIP; LAVAGE, JET

Catalog Number 0210118100

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 interpulse handpiece with coaxial fan spray tip was being used in a hip procedure when it fell off and into the surgical site.The tip was removed by hand, and the procedure was completed successfully.There were no patient or user injuries, and no adverse consequences.

Event Description

It was reported that the interpulse handpiece with coaxial fan spray tip was being used in a hip procedure when it fell off and into the surgical site.The tip was removed by hand, and the procedure was completed 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.Not yet received by manufacturer.

Manufacturer Narrative

While the product is within specification, our investigation has concluded that this event was a result of a variation in the inner diameter for components manufactured between january 16, 2014 and april 4, 2014.The device was scrapped at the manufacturer.

• Brand Name: INTERPULSE HANDPIECE WITH COAXIAL FAN SPRAY 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: 3760742
• MDR Text Key: 4553154
• Report Number: 0001811755-2014-01393
• 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: Nurse
• 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: 0210118100
• Device Lot Number: 14049012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2014
• Initial Date FDA Received: 04/21/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2014
• 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