MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VHS VARIABLE ANGLE 4H PLATE; FIXATION APPLICATION

Model Number N/A

Device Problems Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2014

Event Type  malfunction  

Manufacturer Narrative

The product was not returned with the packaging, so the complaint cannot be verified, but is likely based on the packaging configuration.The packaging configuration was changed to the standard hip stem configuration that prevents product movement within the packaging and did not encounter adhesive flaking during the packaging performance validation.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.Investigation results concluded that the reported event was due to packaging control : package damaged during shipment.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.(b)(4).

Event Description

It was reported that before a hip fracture repair procedure on (b)(6) 2014, the sterile field opened the 4-hole plate and adhesive material flaked off into the packaging and implant.The surgeon did not feel comfortable using the implant.Another plate was opened and used instead.This was not a revision and there was no delay.

• Brand Name: VHS VARIABLE ANGLE 4H PLATE
• Type of Device: FIXATION APPLICATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6903512
• MDR Text Key: 87874550
• Report Number: 0001825034-2017-07385
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK964880
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2021
• Device Model Number: N/A
• Device Catalogue Number: 200104
• Device Lot Number: 586600
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2011
• 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