MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. POWER SUPPLY, EU/KR; LAVAGE, JET

Model Number N/A

Device Problem Sparking (2595)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2020

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Once an evaluation of this device is completed, a follow-up/final report will be submitted.(b)(6).

Event Description

It was reported that there was a spark when the jet lavage cable was plugged in and unplugged from the power pack.The spark occurred directly on the plug connection of the power supply unit.There was no harm or delay involved.No adverse events were reported as a result of this malfunction.

Event Description

No additional event information.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Device is used for treatment.Review of complaint history found no additional related issues for this item and the reported part and lot combination.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The event cannot be confirmed.

Event Description

It was reported that there was a spark when the jet lavage cable was plugged in and unplugged from the power pack.The spark occurred directly on the plug connection of the power supply unit.No one was shocked as a result of the event.There was no harm or delay involved.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Once an evaluation of this device is completed, a follow-up/final report will be submitted.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Visual examination of the returned product/provided pictures identified some damage and browning around the housing of the pulsavac plug-in.Functional testing determined the power supply was not powering on.Review of complaint history identified additional similar complaints for the reported item and no additional complaints for the reported part and lot combination.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.

Event Description

No additional event information.

• Brand Name: POWER SUPPLY, EU/KR
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 10762683
• MDR Text Key: 213876318
• Report Number: 0001526350-2020-00912
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• 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: 00515035001
• Device Lot Number: 63123336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 74