MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO INTERPULSE HANDPIECE SET W/; LAVAGE, JET

Catalog Number 0210918100

Device Problem Disassembly (1168)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2014

Event Type  malfunction  

Event Description

It was reported that the interpulse handpiece set w/10' suction tube was being used in a procedure when the tip fell apart.It was confirmed that no fragments from the tip fell into the surgical site.The procedure was completed successfully with no patient or user injuries, and no adverse consequences.

Manufacturer Narrative

The device was evaluated by the manufacturer and the reported event was confirmed.A definite root cause could not be determined.The device was scrapped at the manufacturer.

Event Description

It was reported that the interpulse handpiece set w/10' suction tube was being used in a procedure when the tip fell apart.It was confirmed that no fragments from the tip fell into the surgical site.The procedure was completed successfully with no patient or user injuries, and no adverse consequences.

Manufacturer Narrative

A follow up report will be filed after the quality investigation has been completed.

• Brand Name: INTERPULSE HANDPIECE SET W/
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 0061 5
• 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: 3731777
• MDR Text Key: 4545301
• Report Number: 0001811755-2014-01208
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2014

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: 0210918100
• Device Lot Number: 14031012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2014
• Initial Date FDA Received: 04/07/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2014
• 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