MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO EZOUT ATTACHMENT, PKG; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 7202100000

Device Problem Leak/Splash (1354)

Patient Problem Vascular Dissection (3160)

Event Date 11/11/2016

Event Type  malfunction  

Event Description

It was reported that during a hip revision case dark fluid/debris was exiting out the bottom of the ezout attachment handle.The debris was noticed specifically on the soft tissue where the distal portion of the attachment shaft was contacting the soft tissue.The surgeon attempted to use pulsed irrigation to remove the debris, which was unsuccessful.The surgeon then removed a thin slice of soft tissue (about 3¿ long by 1¿ wide) to remove all debris.The surgeon stated that there was a minimal surgical delay as a result of this issue.Additional information has been requested from the user facility.

Event Description

It was reported that during a hip revision case dark fluid/debris was exiting out the bottom of the ezout attachment handle.The debris was noticed specifically on the soft tissue where the distal portion of the attachment shaft was contacting the soft tissue.The surgeon attempted to use pulsed irrigation to remove the debris, which was unsuccessful.The surgeon then removed a thin slice of soft tissue (about 3¿ long by 1¿ wide) to remove all debris.The surgeon stated that there was a minimal surgical delay as a result of this issue.There were no further adverse consequences or medical intervention reported with this event.

• Brand Name: EZOUT ATTACHMENT, PKG
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 6176587
• MDR Text Key: 62460846
• Report Number: 0001811755-2016-02851
• Device Sequence Number: 1
• Product Code: HWE
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2017

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: 7202100000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2016
• Initial Date FDA Received: 12/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1