MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZNN INSTRUMENT - TEAR DROP GUIDE WIRE 3.0 MM DIAMETER; ROD, FIXATION

Model Number N/A

Device Problems Contamination /Decontamination Problem (2895); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 09/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Expected, not yet received.

Event Description

It was reported that during incoming inspection at the warehouse, it was discovered that ten products were found to have the seal peeling off and a stain found on the product.Further, there were eight products that were found to have stains on the products only.There was no patient involvement.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Updated: complaint sample was evaluated and the reported event was confirmed.For passivation, the guide wires are placed on a rack with two or more contact points.These contact points cause a small portion of the guide wire to not receive a full passivation coating, leading to an inconsistent coating appearing as a "stain" or mark.These stains are not corrosion, and do not impact the fit, form, or function of the guidewires; they are merely cosmetic.Device analysis indicated that the device met specification.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

No additional information received.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Corrected: remove device code "packaging problem" as it is no longer applicable for this complaint.

Event Description

It was reported that during incoming inspection at the warehouse, it was discovered that eighteen products were found to have a stain found on the product.There was no patient involvement.

• Brand Name: ZNN INSTRUMENT - TEAR DROP GUIDE WIRE 3.0 MM DIAMETER
• Type of Device: ROD, 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: 7938798
• MDR Text Key: 122856896
• Report Number: 0001822565-2018-05503
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK101622
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 47249009700
• Device Lot Number: 64077375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2018
• 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