MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SURGILAV PLUS HANDPIECE SET WITH HIGH FLOW TRAUMA TIP; LAVAGE, JET

Catalog Number 0207560000

Device Problem Disassembly (1168)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2014

Event Type  malfunction  

Event Description

It was reported that the tip was discovered to be broken inside the packaging during a procedure.The procedure was completed successfully with a back up device.There were no patient or user injuries and no adverse consequences.

Manufacturer Narrative

Upon visual inspection of the tip, the claimed condition was confirmed.The tip of the irrigation tube was detached/broken from the tip insert.Glue residues were observed in the end of the irrigation tube, where it connects with the tip part.A definite root cause could not be determined, the device was scrapped at the manufacturer.

Event Description

It was reported that the tip was discovered to be broken inside the packaging during a procedure.The procedure was completed successfully with a back up device.There were 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: SURGILAV PLUS HANDPIECE SET WITH HIGH FLOW TRAUMA 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: 4184851
• MDR Text Key: 5061225
• Report Number: 0001811755-2014-03664
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/22/2014

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: 0207560000
• Device Lot Number: 13336012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2014
• Initial Date FDA Received: 10/20/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1