MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. FAN SPRAY KIT

Model Number N/A

Device Problem Material Rupture (1546)

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

Event Date 09/28/2015

Event Type  malfunction  

Manufacturer Narrative

The product was received on 10/7/2015.The returned unit was received unopened.The seal remained intact and the tyvek, tray materials and shelf carton were not discolored.The battery pack and cover were deformed from becoming hot.One of the anodes had ejected out of the battery pack and into the tray.The battery pack was opened and the batteries were deformed with several batteries having ejected the anodes.The remaining batteries also exhibited evidence of overheating and splitting open.Visual examination of the wiring circuit for presence of damaged wiring did reveal a condition that would have resulted in rapid battery discharge.Inspection of the device found a bare spot on the white and on the black power wires.These bare spots were contiguous and could have shorted out against each other or against the battery terminal contact.Inspection noted pinch marks where the wires had been pinched between the battery pack side wall and the battery terminal contact when the wires looped was installed.The review of the dhr found no specific non-conformances, no rfd¿s or relevant change notices with this production lot.The review of the manufacturing and testing processes discovered no systemic issues with this device.Since the device was still sealed inside the sterile tray this reported event occurred post manufacturing.No modifications or manipulation of the device was possible.The customers reported event was that the pulsavac battery pack had exploded inside the sealed container.This incident was confirmed in this investigation.The cause for the battery pack exploding was due to an electrical short in the battery pack.The electrical short was caused by the two exposed electrical wires found in the battery pack.One or both of the bare spots on the wires caused a catastrophic electrical short when grounded out to the battery terminal contacts or against each other.No issues were discovered in the dhr review or in the review of the manufacturing processes or procedures specifically relevant to this event.The most likely cause for this event is an isolated manufacturing operator error during production.Recommended actions: none - severity and frequency do not warrant further actions.Issue is trended by quality reports.However, photographs of the returned device were forwarded to the product quality engineer for informational purposes only.Disposition of product: device not returned to customer.

Event Description

It was noted during kit inspection prior to surgery, that the pulsavac plus battery pack had exploded.The sterilization case was unopened.The customer used and finished the surgery with an alternative one.

• Brand Name: FAN SPRAY KIT
• Type of Device: FAN SPRAY 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: 5178405
• MDR Text Key: 29934910
• Report Number: 0001526350-2015-00183
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/30/2015

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 Expiration Date: 01/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 00-5150-475-01
• Device Lot Number: 62947113
• Other Device ID Number: N/A
• Initial Date Manufacturer Received: 09/30/2015
• Initial Date FDA Received: 10/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1