MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SIPS DUAL 2 MINUTE TIP; LAVAGE, JET

Catalog Number 0210100000S4

Device Problem Disassembly (1168)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2014

Event Type  malfunction  

Event Description

It was reported that the sips dual 2 minute tip fell off and into the surgical site during a procedure.The tip was removed by hand and the procedure was completed successfully with no patient or user injuries and no adverse consequences.

Manufacturer Narrative

Customer discarded.

• Brand Name: SIPS DUAL 2 MINUTE 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: 3934040
• MDR Text Key: 4535575
• Report Number: 0001811755-2014-02511
• 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
• Type of Report: Initial
• Report Date: 06/19/2014

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: 0210100000S4
• Device Lot Number: 14116012
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/19/2014
• Initial Date FDA Received: 07/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2014
• 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