MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER NATURAL NAIL SYSTEM; INSTRUMENT, TRAUMA

Model Number N/A

Device Problems Failure To Adhere Or Bond (1031); Fracture (1260); Loose or Intermittent Connection (1371)

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

Event Date 09/20/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is being submitted late due to remediation efforts.  report source: foreign.The event occurred in (b)(6).Complaint sample was evaluated and the reported event was confirmed.The device was returned fractured below the threaded portion.The device met print specifications where measured.Upon visual inspection, scratches were present on the shaft.Dents were also present on the impaction portion of the device indicative of use.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to an issue investigated in a previously addressed capa.The need for further corrective action has not been indicated.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 the instrument threads fractured and would not connect tightly to mating product while in use, causing a delay to surgery of 31-60 minutes.No further patient consequences or additional information has been made available.

• Brand Name: ZIMMER NATURAL NAIL SYSTEM
• Type of Device: INSTRUMENT, 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: 6942954
• MDR Text Key: 89235062
• Report Number: 0001822565-2017-06946
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00249003200
• Device Lot Number: 62018725
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2014
• Initial Date FDA Received: 10/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention