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

Catalog Number 89-8510-440-10

Device Problems Break (1069); Mechanical Problem (1384); Separation Failure (2547)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 11/01/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the manufacturer at the date of this report.A follow-up medwatch will be submitted once the investigation is completed or if any additional information is received.

Event Description

It was reported that the aseptic transfer kit housing part number 89-8510-440-10, lot number 5010442 was broken.During the event, another device, aseptic transfer kit housing part number 89-8510-440-10, lot number 5009013 was also detected as broken.The surgery was delayed between 30 to 45 minutes due to the time needed to change the products.There was no additional harm or injury to the patient or operator reported.

Event Description

It was reported that the aseptic transfer kit housing part number 89-8510-440-10, lot number 5010442 was broken.During the event, another device, aseptic transfer kit housing part number 89-8510-440-10, lot number 5009013 was also detected as broken.The surgery was delayed between 30 to 45 minutes due to the time needed to change the products.There was no addtional harm or injury to the patient or operator reported.

Manufacturer Narrative

Aseptic transfer kit housing, lot number 5010442 was returned for complaint investigation.Visual and functional test were performed.Upon receipt, it was confirmed that the contacts were damaged and device had a leakage issue at the level of the lid.Device was not repairable, it was recycled in zimmer geneva premises according to customer instructions.The event date was reported as unknown.

• Brand Name: ASEPTIC TRANSFER KIT HOUSING
• Type of Device: ASEPTIC TRANSFER KIT HOUSING
• Manufacturer (Section D): ZIMMER SURGICAL SA; 3 chemin du pre fleuri; plan-les-ouates; geneva 1228 ; SZ 1228
• MDR Report Key: 8123638
• MDR Text Key: 129030881
• Report Number: 0008031000-2018-00028
• 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
• Type of Report: Initial,Followup
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 89-8510-440-10
• Device Lot Number: 5010442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/07/2018
• Initial Date FDA Received: 12/03/2018
• Supplement Dates Manufacturer Received: 12/03/2018
• Supplement Dates FDA Received: 01/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other