MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM HIP KIT

Model Number N/A

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2015

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to the manufacturer at the time of this report.A follow up medwatch will be submitted once the device has been returned and the investigation is complete.

Event Description

Pulsavac batteries exploded.At time of event the surgery had already been completed and product was located in a cleaning trolley.No harm to operator, patient or anyone.

Manufacturer Narrative

No product was returned for evaluation.The investigation of this complaint is based on the information in this complaint.The device history record review noted no anomalies, or non-conformances with the device or the batteries.The manufacturing process review noted no systemic issues.The customers reported event is that the battery pack was sitting on the cleaning cart after the procedure and exploded.Without the returned device or photographs the reported event cannot be confirmed.With the available information, a determination of a true root cause cannot be made.Historically, the most prevalent cause for the battery pack exploding is due to severing the electrical wire from the battery pack to the hand-piece.Cutting the wire can cause catastrophic electrical short initiating node expulsions of the batteries.The device instructions for use and the labeling on the tyvek lid warn that cutting the battery pack cable could lead to shock, excessive heat and/or sparks, and could result in fire or personal injury.The batteries should be physically removed from the battery pack, care should be taken and personal safety equipment should be worn.The pulsavac hand-piece is normally exposed to biological fluids and as such would be treated as a bio hazardous material after the procedure.Since, the battery pack was sitting on the cleaning cart it is most probable that the electrical wires were severed to remove the battery pack from the hand-piece.Speculatively, the most likely cause for this incident is improper disposal of the device in contradiction of the ifu warnings by the customer.

• Brand Name: PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM HIP KIT
• Type of Device: PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM HIP KIT
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: jennifer hutchison ; 200 west ohio avenue; dover, OH 44622 ; 3303438801
• MDR Report Key: 5151080
• MDR Text Key: 28746739
• Report Number: 0001526350-2015-00171
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 11/09/2015

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 Model Number: N/A
• Device Catalogue Number: 00-5150-482-00
• Device Lot Number: 63040196
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1