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

Catalog Number 0210110100

Device Problems Overheating of Device (1437); Smoking (1585)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 02/03/2015

Event Type  malfunction  

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.

Event Description

It was reported that after 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

Evaluation in progress.

Manufacturer Narrative

The device will not be returned for analysis; it is not possible to determine the cause of the reported event without an evaluation of the device.Device was was not returned to stryker for evaluation.

Event Description

It was reported that after 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 after 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.

• Brand Name: INTERPULSE HANDPIECE WITH COAXIAL BONE CLEANING TIP
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 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: 4560724
• MDR Text Key: 5559784
• Report Number: 0001811755-2015-00730
• 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

• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2015
• Initial Date FDA Received: 03/02/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/03/2015; 03/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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