MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. PULS PLUS FAN SPRAY KIT; JET, LAVAGE

Catalog Number 00515047501

Device Problems Expulsion (2933); Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2019

Event Type  malfunction  

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).Once the investigation is complete, a follow up/final report will be submitted.

Event Description

It was reported that during the surgery, water pressure on high mode of this product is too low to use.The event occurred during surgery with a delay between 0-15 minutes, but an alternate device was available for use.Upon checking the product, the batteries inside the device had leaked.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

Udi#: (b)(4).Reported issue: it was reported that during the surgery, water pressure on high mode of this product is too low to use.Dhr review: the device history record (dhr) for catalog #: 00515047501 lot number: 64177772, review noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.Technical review and physical evaluation: on (b)(6) 2019, it was reported from (b)(6) hospital that during the surgery, water pressure on high mode of this product is too low to use.On 04 september 2019, a returned product investigation was performed on the 00515047501.The physical evaluation revealed that the device had a corrosion within the battery pack, as well as low total battery voltage.The results of the returned product investigation have confirmed the reported event.Probable cause/root cause: while the returned product investigation confirmed that the 00515047501 had low water pressure due to low battery voltage, it cannot be determined from the information provided what actually caused the reported event.Therefore, based on the information provided, a specific root cause of the reported event cannot be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Conclusion: review of the information provided during the investigation determined there is no further actions needed at this time (ie/capa/scar/hhe/d).This complaint will be tracked and trended for any adverse trends that may warrant further action.

Event Description

No additional event information.

• Brand Name: PULS PLUS FAN SPRAY KIT
• Type of Device: JET, LAVAGE
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8871794
• MDR Text Key: 153836924
• Report Number: 0001526350-2019-00639
• 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
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 00515047501
• Device Lot Number: 64177772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/02/2019
• Initial Date FDA Received: 08/07/2019
• Supplement Dates Manufacturer Received: 09/16/2019
• Supplement Dates FDA Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1