MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZNN TEAR DROP GUIDE WIRE 3.0 MM DIAMETER 100 CM LENGTH ROD, FIXATION

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 08/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4). 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.

Event Description

It is reported that upon receipt at the distributorship, there was a stain found on the product. There was no adverse events reported as a result of this malfunction as there was no patient involvement.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information. Updated: reported stains were confirmed by visual examination. It was determined the stain was caused by the way the tear drop guide wires are fixtured during 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. The product is conforming per zimmer biomet's criteria. No product problem has been identified and the devices conform to their specifications. 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 further information available.

• Brand Name: ZNN TEAR DROP GUIDE WIRE 3.0 MM DIAMETER 100 CM LENGTH
• 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: 7850373
• Report Number: 0001822565-2018-04813
• 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
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 47249009700
• Device Lot Number: 64063044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2018

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 12/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2018
• 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