MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO FAN SPRAY TIP WITH SOFT CONE SPLASH SHIELD; LAVAGE, JET

Catalog Number 0207055000

Device Problem Disassembly (1168)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2014

Event Type  malfunction  

Event Description

It was reported that the fan spray tip with soft cone splash shield was being used in a procedure when the tip broke off and came out of the gun.It was confirmed that the tip did not fall into the surgical site.The procedure was completed successfully, with no patient or user injuries and no adverse consequences.

Event Description

It was reported that the fan spray tip with soft cone splash shield was being used in a procedure when the tip broke off and came out of the gun.It was confirmed that the tip did not fall into the surgical site.The procedure was completed successfully, with no patient or user injuries and no adverse consequences.

Event Description

It was reported that the fan spray tip with soft cone splash shield was being used in a procedure when the tip broke off and came out of the gun.It was confirmed that the tip did not fall into the surgical site.The procedure was completed successfully, with no patient or user injuries and no adverse consequences.

Manufacturer Narrative

Upon visual inspection of the tip, the claimed condition was confirmed.The suction tube was detached/dislodged from the tip insert, and the irrigation tube was broken (possibly as result of the detachment of the suction tube).Glue residues were observed in the end of the suction tube, where it connects with the tip insert.At this time a specific root cause cannot be determined.The device was scrapped at the manufacturer.

Manufacturer Narrative

A follow up report will be filed after the device is received and the quality investigation has been completed.

Manufacturer Narrative

The surgilav plus handpiece set, (b)(4), lot no 14049012, was investigated and deemed a concomitant product to this report.

• Brand Name: FAN SPRAY TIP WITH SOFT CONE SPLASH SHIELD
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; highway #3, km 130.2; kalamazoo MI 49001 006
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo MI 49001 006
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 3900689
• MDR Text Key: 4428554
• Report Number: 0001811755-2014-02308
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/03/2014

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: 0207055000
• Device Lot Number: 14111012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2014
• Initial Date FDA Received: 06/27/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/13/2014; 08/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: SURGILAV PLUS HP SET (B)(4), LOT: 04049012