MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER NATURAL NAIL SYSTEM GUIDE WIRE GRIPPER; PASSER, WIRE

Model Number N/A

Device Problem Device Operational Issue (2914)

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

Event Date 01/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the device is in the process of being returned to zimmer biomet for evaluation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the guide wire gripper does not grip.There was no patient involvement, as this was discovered during sterilization.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Upon reassessment of the reported event, it was determined that this complaint is a duplicate complaint.It is also noted to be a not reportable event, as this event was found in sterilization and had no patient interaction or impact.The initial reported was forwarded in error and should be voided.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.

• Brand Name: ZIMMER NATURAL NAIL SYSTEM GUIDE WIRE GRIPPER
• Type of Device: PASSER, WIRE
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6543844
• MDR Text Key: 74399504
• Report Number: 0001822565-2017-03027
• Device Sequence Number: 1
• Product Code: HXI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2017

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 Model Number: N/A
• Device Catalogue Number: 00249001200
• Device Lot Number: 62597689
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2017
• Initial Date FDA Received: 05/04/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1