MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER NATURAL NAIL TEAR DROP GUIDE WIRE 3.0MM; ROD, FIXATION

Model Number N/A

Device Problems Material Discolored (1170); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 06/14/2018

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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-03698, 0001822565-2018-03702, 0001822565-2018-03704, 0001822565 - 2018 - 03706, 0001822565-2018-03707, 0001822565-2018-03708, 0001822565-2018-03709, 0001822565-2018-03711, 0001822565-2018-03712, 0001822565-2018-03715, 0001822565-2018-03716, 0001822565-2018-03717, 0001822565-2018-03718, 0001822565-2018-03719, 0001822565-2018-03720, 0001822565-2018-03721, 0001822565-2018-03722, 0001822565-2018-03723, 0001822565-2018-03724, 0001822565-2018-03725, 0001822565-2018-03727, 0001822565-2018-03728, 0001822565-2018-03729, 0001822565-2018-03730.

Event Description

It is reported that during incoming product inspection, there was an unknown stain/contamination found on the sterile guide wire.There were no adverse events as a result of this malfunction, as there was no patient involvement.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected information.Reported stains was confirmed by visual examination.Are 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 event information available at the time of this report.

• Brand Name: ZIMMER NATURAL NAIL TEAR DROP GUIDE WIRE 3.0MM
• 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: 7770034
• MDR Text Key: 116712880
• Report Number: 0001822565-2018-03726
• 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: 08/09/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 47249009800
• Device Lot Number: 64006747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2018
• 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