MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO INTERPULSE HANDPIECE WITH HIGH FLOW TIP; MIXER, CEMENT, FOR CLINICAL USE

Catalog Number 0210114000

Device Problem Disassembly (1168)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/27/2014

Event Type  malfunction  

Event Description

It was reported that during a surgical procedure at the user facility the tip was falling off the device.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.

Event Description

It was reported that during a surgical procedure at the user facility, the tip was falling off the device.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

The device was not returned for analysis.

Manufacturer Narrative

Further information was received from the account stating the tip was not falling off the device, the trigger would not stay locked and the surgeon had to continually press it to complete the procedure.The manufacturer no longer considers this a reportable event based on this new information.

• Brand Name: INTERPULSE HANDPIECE WITH HIGH FLOW TIP
• Type of Device: MIXER, CEMENT, FOR CLINICAL USE
• 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: 4355848
• MDR Text Key: 5177678
• Report Number: 0001811755-2014-04648
• Device Sequence Number: 1
• Product Code: JDZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0210114000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2015
• Was Device Evaluated by Manufacturer?: No
• 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