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

Catalog Number 7202100000

Device Problem Leak/Splash (1354)

Patient Problem Skin Discoloration (2074)

Event Date 05/24/2017

Event Type  malfunction  

Event Description

It was reported that during a surgical procedure at the user facility the ezout attachment discolored along with the tissue and skin of the patient.The procedure was completed successfully without a clinically significant delay; no medical intervention was reported.

Manufacturer Narrative

Device not returned to manufacturer for evaluation.

Event Description

It was reported that during a surgical procedure at the user facility the ezout attachment discolored along with the tissue and skin of the patient.The procedure was completed successfully without a clinically significant delay; no medical intervention was reported.

• Brand Name: EZOUT ATTACHMENT
• 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: 6665094
• MDR Text Key: 78357600
• Report Number: 0001811755-2017-01338
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/29/2017

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/29/2017
• Initial Date FDA Received: 06/23/2017
• Supplement Dates Manufacturer Received: 09/28/2017
• Supplement Dates FDA Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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