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 Information (3190)

Event Date 01/23/2015

Event Type  malfunction  

Event Description

It was reported that at the user facility, the tips of the handpieces were falling apart.No further information regarding this event was available from the user facility.

Manufacturer Narrative

The unit was not available (not returned) to stryker puerto rico (spr) for evaluation since it was discarded.Therefore, the claimed condition was not confirmed.Product was discarded by the customer.

Event Description

It was reported that at the user facility, the tips of the handpieces were falling apart.No further information regarding this event was available from the user facility.

Manufacturer Narrative

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

• Brand Name: INTERPULSE HANDPIECE WITH COAXIAL FAN SPRAY 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: 4537258
• MDR Text Key: 5520369
• Report Number: 0001811755-2015-00576
• 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
• Type of Report: Initial,Followup
• Report Date: 01/23/2015

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: 0210118100
• Device Lot Number: 14019012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/18/2015
• Initial Date FDA Received: 02/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2014
• 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