MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TEAR DROP GUIDE WIRE; GUIDE, SURGICAL, INSTRUMENT

Model Number N/A

Device Problems Device Packaging Compromised (2916); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 04/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (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.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

It was reported that the package was found defective and foreign substance was found in on the inside of the package.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was confirmed.Evaluation of the returned device, debris inside the packaging was identified.The debris in the packaging was sent for further testing and is consistent with acrylonitrile butadiene styrene abs plastic.Dhr was reviewed and no discrepancies relevant to the reported event were found.A manufacturing deficiency is considered as the root cause of the reported issue.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: TEAR DROP GUIDE WIRE
• Type of Device: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7505438
• MDR Text Key: 107991223
• Report Number: 0001822565-2018-02576
• Device Sequence Number: 1
• Product Code: FZX
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 47249009701
• Device Lot Number: 63926832
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1