MAUDE Adverse Event Report: ZIMMER SURGICAL SA ASEPTIC TRANSFER KIT HOUSING

Model Number N/A

Device Problem Defective Device (2588)

Patient Problem No Information (3190)

Event Date 04/30/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).After several attempts, the device will not be returned to the manufacturer.Therefore, it could not be inspected in an effort to confirm the defect.Device history record review could not performed as the lot number remains unknown.A follow-up medwatch will be submitted if the product is returned or if additional information is received.

Event Description

It was reported that the aseptic transfer kit housing (atk) part number 89-8510-440-10 was not working as intended and it opened during surgery.Despite attempts, it was not possible to know the lot number of the product or if the event occured in the sterile area.No extension of surgery was reported.There was no harm or injury to patient/operator reported.

• Brand Name: ASEPTIC TRANSFER KIT HOUSING
• Type of Device: ASEPTIC TRANSFER KIT HOUSING
• Manufacturer (Section D): ZIMMER SURGICAL SA; 3, ch. du pre fleuri; 1228 plan-les-ouates; geneva CH-12 28; SZ CH-1228
• Manufacturer (Section G): ZIMMER SURGICAL SA; 3, ch. du pre fleuri; 1228 plan-les-ouates; geneva CH-12 28; SZ CH-1228
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 9528981
• MDR Text Key: 177850674
• Report Number: 0008031000-2019-00022
• Device Sequence Number: 1
• Product Code: MOQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 89-8510-440-10
• Device Lot Number: NOT COMMUNICATED
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other