MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JGRKNT 1.0MM MINI 2-0 NDLS; FASTENER, FIXATION

Model Number N/A

Device Problems Fracture (1260); Difficult To Position (1467); Device Difficult to Setup or Prepare (1487)

Patient Problem No Patient Involvement (2645)

Event Date 05/18/2015

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation due to the device remains implanted.Review of the dhr and complaint history did not identify any anomalies or adverse events.Without the opportunity to evaluate the device, the root cause was unable to be determine and the complaint was not confirmed.A summary of the investigation has been sent to the complainant.Telephone number : (b)(6).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.This report is being submitted late as it has been identified in remediation.Zimmer biomet complaint (b)(4).

Event Description

It was reported that, during an unknown procedure on (b)(6) 2015, the anchor did not hold on the inserter.Surgeon tried to put the anchor back on the inserter, but after the third attempt, the anchor was torn.The procedure was finished by using another anchor.This occurred outside of the patient and therefore did not contribute to any patient injury.There was also no reported delay in the procedure.

• Brand Name: JGRKNT 1.0MM MINI 2-0 NDLS
• Type of Device: FASTENER, 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: 6956063
• MDR Text Key: 90474378
• Report Number: 0001825034-2017-09015
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: PK110879
• 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

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: N/A
• Device Catalogue Number: 912076
• Device Lot Number: 956800
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2014
• 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