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

Model Number N/A

Device Problems Battery Problem (2885); Expulsion (2933)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during use in the operating room, the pulsavac battery pack exploded.They removed the full set from the operating room and opened a new package.There was no delay or other issues, and this was the first and only time it has happened.The electrical cable was cut after the battery explosion.They only kept the battery pack.No adverse events were reported as a result of this malfunction.

Event Description

The customer claims the pulsavac battery pack exploded during use in the or.They removed the full set from the or and opened a new package.There was no delay or other issues, and this was the first and only time it has happened.The electrical cable was cut after the battery explosion.They only kept the battery pack.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Udi#: (b)(4)> the device history record (dhr) for 00515048601 lot number z000010703, 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.On (b)(6) 2018, it was reported from sykehuset i vestfold hf, tonsberg that the customer claims the pulsavac battery pack exploded during use in the or.A returned product investigation could not be performed for the reported event due to the product not being returned for evaluation.The reported event can therefore not be confirmed.Although the reported event was confirmed via pictures sent from the customer, it cannot be determined from the information provided what caused the issue.Therefore, the root cause could not be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

• Brand Name: HIP KIT
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 7758732
• MDR Text Key: 116874445
• Report Number: 0001526350-2018-00619
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 00515048601
• Device Lot Number: Z000010703
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1