MAUDE Adverse Event Report: ZIMMER SURGICAL SA BATTERY FOR ASEPTIC TRANSFER KIT

Catalog Number 89-8510-440-20

Device Problems Component Falling (1105); Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/31/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the battery 89-8510-440-20, serial number (b)(4) was dropped and not tight enough.A surgery delay of 1 hour was reported.No back-up device was available.There was no additional harm or injury to patient/operator reported.

Manufacturer Narrative

Battery for aseptic transfer kit, serial number (b)(4) was not returned for complaint investigation.Therefore, the device could not be visually inspected in an effort to confirm the defect.Design history record review was performed and no issue was discovered during the manufacturing process that could explain the defect reported.A follow-up medwatch will be submitted if the product is returned or if additional information is received.

• Brand Name: BATTERY FOR ASEPTIC TRANSFER KIT
• Type of Device: BATTERY FOR ASEPTIC TRANSFER KIT
• Manufacturer (Section D): ZIMMER SURGICAL SA; chemin du pre fleuri, 3; plan-les-ouates, geneva CH-12 28; SZ CH-1228
• MDR Report Key: 7298672
• MDR Text Key: 101002578
• Report Number: 0008031000-2018-00007
• 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
• Type of Report: Initial,Followup
• Report Date: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 89-8510-440-20
• Device Lot Number: 5007449
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other