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

Catalog Number 0210110100

Device Problems Overheating of Device (1437); Smoking (1585); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Patient Involvement (2645); No Information (3190)

Event Date 02/03/2015

Event Type  malfunction  

Event Description

It was reported that prior to a surgical procedure at the user facility, the device was overheating.The procedure was completed successfully with the same device.No adverse consequences, medical intervention or delay were reported.

Event Description

It was reported that prior to a surgical procedure at the user facility the device was overheating.The procedure was completed successfully with the same device.No adverse consequences, medical intervention or delay were reported.

Manufacturer Narrative

Updated to reflect that it was reported that prior to a surgical procedure at the user facility the device was overheating.The procedure was completed successfully with the same device.No adverse consequences, medical intervention or delay were reported.

Manufacturer Narrative

As per manufacturing task instructions mti-sip-01-021 rev.L, the correct way to put the batteries inside the battery holder is in an inverted (backwards) position.Therefore no failure was detected.Per follow up with customer and manufacturing instructions, there was no known problem found with the device.The customer forgot they are required to turn the batteries around before starting to use the device, this was due to user error.

Event Description

It was reported that during a surgical procedure at the user facility, the device was overheating.Additional information has been requested from the user facility.

Manufacturer Narrative

Evaluation in progress.

• Brand Name: INTERPULSE HANDPIECE WITH COAXIAL BONE CLEANING 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: 4560745
• MDR Text Key: 5458354
• Report Number: 0001811755-2015-00731
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0210110100
• Device Lot Number: 14335012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• 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