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

Model Number N/A

Device Problems Unsealed Device Packaging (1444); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 06/25/2018

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 all associated reports: 0001822565-2018-03933, 0001822565-2018-03940, 0001822565-2018-03941, 0001822565-2018-03942, 0001822565-2018-03943, 0001822565-2018-03944, 0001822565-2018-03945, 0001822565-2018-03946, 0001822565-2018-03947.

Event Description

It was reported during the incoming inspection of the product at the distributorship, a foreign substance was found in the package and a crease was noted in the sealing area.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Evaluation of the eight (8) returned products confirmed the presence of crease and/or fold in the seal of the pouches.Device history record was reviewed and no discrepancies were found.A manufacturing deficiency was 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.

Event Description

It was reported during the incoming inspection of the product at the distributorship, a crease was noted in the sealing area.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: ZNN 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: 7804783
• MDR Text Key: 117857851
• Report Number: 0001822565-2018-03944
• 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: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: No
• 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: 47249009700
• Device Lot Number: 64006741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0542-2019
• Patient Sequence Number: 1