MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEM NAIL TROCH RT 10.5MMX400MM; PROSTHESIS, TRAUMA

Model Number N/A

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 08/11/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Complaint sample was evaluated and the reported event was confirmed.The sample part was reviewed and observed to have punctured through the packaging barrier system which occurred during shipping.The packaging bom has been changed to provide more protection and hold the product in place.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.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 the packaging was discovered to be torn during a right femoral nail surgery.A different nail was used to complete the procedure without delay.No adverse events have been reported as a result of the malfunction.

• Brand Name: FEM NAIL TROCH RT 10.5MMX400MM
• Type of Device: PROSTHESIS, TRAUMA
• 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: 6954081
• MDR Text Key: 90459289
• Report Number: 0001825034-2017-08787
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: PK072161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/17/2017

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: 12/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 14-443440
• Device Lot Number: 695750
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2015
• Initial Date FDA Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2009
• 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