MAUDE Adverse Event Report: ZIMMER SURGICAL ZIMMER PULSAVAC PLUS HIP KIT

Catalog Number 00-5150-482-01

Device Problems Thermal Decomposition of Device (1071); Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/03/2014

Event Type  malfunction  

Event Description

It was reported that after surgery, the zimmer pulsavac plus hip kit exploded twice in the medical garbage bin after it was disposed of and the bin has changed shape.Additionally, when the device was put in the garbage bin, it started to move.No inflammable things were in the bin.The product was disposed of by the customer because it was burned.There was no patient/user harm or delay of the surgery reported.

Manufacturer Narrative

The complaint could not be confirmed.The device was not returned.The most likely cause for the batteries to explode, as defined by the warning instructions from the battery manufacturer is for the batteries to short out or to develop excessive heat whereby causing a fire to initiate the explosion.Based on the customer's report that the device was burnt it is most probable that the device caused a small fire.The conditions at the time of the incident and the contents of the medical waste container are unknown.However, the potential for the batteries to explode is addressed in the ifu and in the risk assessment.Conjecture indicates that when the device was discarded, the trigger was bumped and activated the device.The device when activated would cause the device to expel the liquid that remained in the tubing.Any liquid contact has the potential to short the battery pack causing it to heat up.The root cause of this incident is most likely the improper disposal of the device.

• Brand Name: ZIMMER PULSAVAC PLUS HIP KIT
• Type of Device: ZIMMER PULSAVAC PLUS HIP KIT
• Manufacturer (Section D): ZIMMER SURGICAL; 200 west ohio ave.; dover OH 44622
• Manufacturer Contact: kathleen smith ; 200 west ohio ave.; dover, OH 44622 ; 3303438801
• MDR Report Key: 3982991
• MDR Text Key: 4752987
• Report Number: 1526350-2014-00387
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/03/2014

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 Catalogue Number: 00-5150-482-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/03/2014
• Initial Date FDA Received: 07/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1