MAUDE Adverse Event Report: ZIMMER, INC. TEAR DROP GUIDE WIRE 3.0 MM DIAMETER 70 CM LENGTH; ROD, FIXATION

Catalog Number 47249009800

Device Problem Unsealed Device Packaging (1444)

Patient Problem Not Applicable (3189)

Event Type  malfunction  

Manufacturer Narrative

Reference: (b)(4).Udi -(b)(4).Foreign source - (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.

Event Description

It was reported that during incoming inspection the sterile packaging on a tear drop guide wire packaging is defective.A crease was found in the sealing area.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation will be sent to the complainant.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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 3.0 MM DIAMETER 70 CM LENGTH
• Type of Device: ROD, FIXATION
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6564909
• MDR Text Key: 75103041
• Report Number: 0001822565-2017-03274
• 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: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 47249009800
• Device Lot Number: 63585007
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/14/2017
• Initial Date FDA Received: 05/12/2017
• Supplement Dates Manufacturer Received: 02/13/2018; 02/23/2018
• Supplement Dates FDA Received: 02/14/2018; 02/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2017
• 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