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

Catalog Number 89-8510-440-20

Device Problems Battery Problem (2885); Appropriate Term/Code Not Available (3191)

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

Event Date 04/09/2019

Event Type  Injury  

Manufacturer Narrative

(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 additional information is received.

Event Description

It was reported that the battery for aseptic transfer kit 89-8510-440-20 serial number (b)(4)was malfunctioning during the surgery.The patient was under anesthesia when the surgeon started the incision.An extension of surgery of 60 minutes was reported.The extension of the surgery is due to the time needed to replace the device.There was no additional harm or injury to patient/operator reported.

Event Description

It was reported that the battery for aseptic transfer kit 89-8510-440-20 serial number (b)(4) was malfunctioning during the surgery.The patient was under anesthesia when the surgeon started the incision.An extension of surgery of 60 minutes was reported.The extension of the surgery is due to the time needed to replace the device.There was no additional harm or injury to patient/operator reported.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Battery for atk, serial number (b)(4), part number 89-8510-440-20 was not returned for complaint investigation.Therefore, the device could not be visually inspected in an effort to confirm the defect.However, a visual diagnosis has been performed based on the received pictures, no failure was observed.Design history record review was performed and no issue was discovered during the manufacturing process that could explain the defect reported.It was reported that the device will be scrapped in the distributor site.A follow up medwatch will be submitted 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: 8586582
• MDR Text Key: 144281796
• Report Number: 0008031000-2019-00015
• 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: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 89-8510-440-20
• Device Lot Number: 5011401
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other