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

Model Number N/A

Device Problem Dent in Material (2526)

Patient Problem No Patient Involvement (2645)

Event Date 10/05/2018

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.

Event Description

It is reported that upon incoming product inspection the product was found with a crease in the sealing area which could potentially compromise sterility.No adverse events were a result of this malfunction as there was no patient involvement.

Event Description

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

Manufacturer Narrative

Review of the packaging determined that no failure was found as the products are within specification(s).No further investigation or action is required after review.The initial report was forwarded in error and should be voided.

• Brand Name: 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
• MDR Report Key: 8032334
• MDR Text Key: 126081415
• Report Number: 0001822565-2018-06045
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K101622
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• 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: 47249009700
• Device Lot Number: 64053678
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1