MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO IRRIGATION HIGH FLOW TIP; LAVAGE, JET

Catalog Number 0210015000

Device Problems Disassembly (1168); Fracture (1260)

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

Event Date 06/22/2015

Event Type  malfunction  

Event Description

It was reported that during a surgical procedure at the user facility the tip of the device fractured and disassembled.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.

Manufacturer Narrative

Device has not yet been returned for evaluation.

Manufacturer Narrative

The device is not available for return.

Event Description

It was reported that during a surgical procedure at the user facility the tip of the device fractured and disassembled.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.

• Brand Name: IRRIGATION HIGH FLOW TIP
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 4918914
• MDR Text Key: 16231543
• Report Number: 0001811755-2015-02587
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/22/2015

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: 0210015000
• Device Lot Number: 14290012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/22/2015
• Initial Date FDA Received: 07/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2014
• 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