MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. COMPONENT KIT; LAVAGE, JET

Catalog Number 00515042000

Device Problem Expulsion (2933)

Patient Problem No Patient Involvement (2645)

Event Date 06/27/2019

Event Type  malfunction  

Manufacturer Narrative

The event recorded by zimmer biomet under (b)(4).Customer has indicated that product is in the process of being returned to zimmer biomet for investigation.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that during surgery when unpacking pulsavac wound debridement system in (b)(6) hospital, iron rust fluids dropped from the part of battery.No patient involvement.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded under zimmer biomet complaint number (b)(4).D4: udi #: (b)(4).Reported issue: when unpacking pulsavac wound debridement system in (b)(6) hospital, iron rust fluids dropped from the part of battery.Dhr review: the device history record (dhr) for 00515042000 lot number 62, 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 04 july 2019, it was reported from (b)(6) hospital that iron rust fluids dropped from the part of battery.On 12 august 2019, a returned product investigation was performed on the 00515042000.The physical evaluation revealed that the device packaging was returned opened, and further review noted corrosion in the battery pack and evidence of rust spots from within the sealed area.The results of the returned product investigation have confirmed the reported event.Probable cause/root cause: while the returned product investigation confirmed that the 00515042000 was not functioning as intended due to a corroded battery, 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.

Event Description

No additional event information available.

• Brand Name: COMPONENT KIT
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8831322
• MDR Text Key: 152520287
• Report Number: 0001526350-2019-00586
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 08/14/2019

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: 02/28/2021
• Device Catalogue Number: 00515042000
• Device Lot Number: 63938715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/04/2019
• Initial Date FDA Received: 07/26/2019
• Supplement Dates Manufacturer Received: 08/14/2019
• Supplement Dates FDA Received: 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1