MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZNN TEAR DROP GUIDE WIRE 3.0 MM DIAMETER 70 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 07/23/2018

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.(b)(4).(b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 04572, 0001822565 - 2018 - 04574, 0001822565 - 2018 - 04575, 0001822565 - 2018 - 04576.

Event Description

It was reported that upon incoming inspection at the warehouse, it was discovered that there was staining found on the product.No adverse events occurred, as there was no patient involvement.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Upon receipt of additional information, it has been determined that the reported device did not cause or contribute to the event.

Event Description

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

• Brand Name: ZNN TEAR DROP GUIDE WIRE 3.0 MM DIAMETER 70 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: 7803185
• MDR Text Key: 117836176
• Report Number: 0001822565-2018-04573
• 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: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 47249009800
• Device Lot Number: 64048686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1