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

Catalog Number 0210014000

Device Problem Disassembly (1168)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/01/2015

Event Type  Injury  

Event Description

It was reported that at the during a surgical procedure at the user facility the tip of the device disassembled and was retained in the surgical site of the patient.The device was removed from the surgical site four days later during a previously scheduled procedure.No additional adverse consequences were noted after the piece of the device was removed from the patient.

Event Description

It was reported that at the during a surgical procedure at the user facility the tip of the device disassembled and was retained in the surgical site of the patient.The device was removed from the surgical site four days later during a previously scheduled procedure.No additional adverse consequences were noted after the piece of the device was removed from the patient.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device not returned.

• Brand Name: 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 0061 5
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; highway #3, km 130.2; kalamazoo MI 49001 006
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 4776038
• MDR Text Key: 5794475
• Report Number: 0001811755-2015-01787
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/23/2015,04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0210014000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/23/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/23/2015
• Initial Date Manufacturer Received: 06/03/2015
• Initial Date FDA Received: 05/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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