MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STRAIGHT WIRE 3.2MM X 98CM; APPLIANCE, FIXATION

Model Number N/A

Device Problems Material Puncture/Hole (1504); Shipping Damage or Problem (1570)

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

Event Date 11/25/2014

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The complaint was confirmed and was due to the old style of tip protector being prone to allowing damage to the sterile barrier system during shipping and handling.The bill of material for this item has already been update to the polyurethane tip protector, which offers superior puncture resistance and a design that does not allow for product/sterile barrier interaction.Review of device history records found these units were released to distribution with no deviations or anomalies.Review of complaint history found no additional issues for these lots.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.

Event Description

It was reported that patient underwent an left hip intramedullary nailing procedure.During the procedure, two different straight wire packages were found with the wires punctured through the inner sterile packaging.There was no reported patient injury or delay in the procedure as a result of the event.

• Brand Name: STRAIGHT WIRE 3.2MM X 98CM
• Type of Device: APPLIANCE, FIXATION
• 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: 6910173
• MDR Text Key: 88158831
• Report Number: 0001825034-2017-07619
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK831005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Model Number: N/A
• Device Catalogue Number: 27949
• Device Lot Number: 265033
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2005
• 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