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 Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Date 04/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - the event occurred in (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 was reported that the package was found defective.There was a crease in the sealing area that compromised sterility.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Upon receiving additional information on the reported event, it was determined to be not reportable as visual inspection of the returned sealed pouch determined to be conforming to specifications.

• 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: 7535570
• MDR Text Key: 108999482
• Report Number: 0001822565-2018-02769
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: PK101622
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 47249009700
• Device Lot Number: 63943990
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1