MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO COAXIAL FEMORAL CANAL TIP; LAVAGE, JET

Catalog Number 0210007000

Device Problem Disassembly (1168)

Patient Problem No Patient Involvement (2645)

Event Date 06/13/2014

Event Type  malfunction  

Event Description

It was reported that prior to opening the packaging of the coaxial femoral canal tip it was observed that the o-ring on the bottom of the tip was cracked.This was noticed on receipt of the device, there was no patient involvement and no associated procedure.There were no user injuries or adverse consequences.

Manufacturer Narrative

Upon investigation it was determined that this event was reported in error.There are no foreseeable health risks to the patient, only customer dissatisfaction due to less suction or irrigation capacity resulting from potential leak if used.According to event details, there was no patient involvement, as the condition was observed prior to use.This condition can be easily detected by the user upon visual inspection.

Event Description

It was reported that prior to opening the packaging of the coaxial femoral canal tip it was observed that the o-ring on the bottom of the tip was cracked.This was noticed on receipt of the device, there was no patient involvement and no associated procedure.There were no user injuries or adverse consequences.

Manufacturer Narrative

A follow-up report will be filed after the device is received and the quality investigation has been completed.Not yet received by manufacturer.

• Brand Name: COAXIAL FEMORAL CANAL 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: 3925664
• MDR Text Key: 19592625
• Report Number: 0001811755-2014-02454
• 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,Followup
• Report Date: 06/13/2014

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: 0210007000
• Device Lot Number: 11026012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/16/2014
• Initial Date FDA Received: 07/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/07/2014
• 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