MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 4.0MM CANC CANN TAP S-CP 70MM; TAP, BONE

Model Number N/A

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation due to unknown location.Reported event was unable to be confirmed due to limited information received from the customer.Based on dhrs, the product was made to print and correct materials.Product left conforming to print as there was no evidence that states otherwise.Review of the complaint history determined that no further action is required as no were trends identified.The packaging appeared to be missing product as stated in the complaint, but unable to determine the root cause since packaging wasn't returned.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.(b)(4).

Event Description

It was reported that the product was missing from the packaging when the product arrived in warehouse.The inner bag was sealed.There was no patient involvement in this case.

• Brand Name: 4.0MM CANC CANN TAP S-CP 70MM
• Type of Device: TAP, BONE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6919071
• MDR Text Key: 88412415
• Report Number: 0001825034-2017-08054
• Device Sequence Number: 1
• Product Code: HWX
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 824162000
• Device Lot Number: CA5BA82
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1