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

Catalog Number 47249009800

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2016-04892, 0001822565-2017-06259, 0001822565-2017-06260.Udi # - (b)(4).Complaint sample was evaluated and the reported event was confirmed.The received outer pouch is only sealed on one end and doesn't appear to have ever been sealed.Root cause can be attributed to inadequate sealing of the pouch during the packaging process.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 that tear drop guide wires sterile packaging was found unsealed during inspection.

• 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: 6839098
• MDR Text Key: 84648547
• Report Number: 0001822565-2017-06259
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 47249009800
• Device Lot Number: 63450617
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2016
• 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