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

Catalog Number 89-8510-440-10

Device Problems Mechanical Problem (1384); Separation Failure (2547); Detachment of Device or Device Component (2907)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2021

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint cmp (b)(4).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.Additional information regarding the contact name is the surgeon one but the email address belongs to the complainant from the same hospital.

Event Description

It was reported that the closure of the aseptic transfer kit housing part number 89-8510-440-10 lot number 5012572 disassembled into its individual parts during the sawing process of a knee endoprosthesis surgery and fell into the operating room area.According to the information received, the event was reported by the user to the (b)(6).This event is related to a malfunction that could potentially lead to a serious injury.Also, a delay of around 30 minutes in the surgery procedure was reported.The reason for the delay was the time needed to clean the operating room area.There was no additional harm or injury to patient/operator reported.

Event Description

It was reported that the closure of the aseptic transfer kit housing part number 89-8510-440-10 lot number 5012572 disassembled into its individual parts during the sawing process of a knee endoprosthesis surgery and fell into the operating room area.According to the information received, the event was reported by the user to the german health authority: bfarm.This event is related to a malfunction that could potentially lead to a serious injury.Also, a delay of around 30 minutes in the surgery procedure was reported.The reason for the delay was the time needed to clean the operating room area.There was no additional harm or injury to patient/operator reported.

Manufacturer Narrative

Zimmer biomet (b)(4).Aseptic transfer kit housing part number 89-8510-440-10; lot number 5012572 was returned for complaint investigation.Upon receipt, it was confirmed that the locking system was disassembled.The device was not repairable, it was sent back to customer unrepaired with discharge letter as per customer instructions.Also, a device history records review was performed for this product part number 89-8510-440-10; lot number 5012572.No issue was found during the manufacturing process that could explain the defect 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; plan-les-ouates; geneva 1228 ; SZ 1228
• MDR Report Key: 11213578
• MDR Text Key: 229324445
• Report Number: 0008031000-2021-00001
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2021

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: 5012572
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2021
• Initial Date FDA Received: 01/22/2021
• Supplement Dates Manufacturer Received: 04/13/2021
• Supplement Dates FDA Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 85 YR