MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CORTICAL SCREW 3.5 X 12MM; PLATE, FIXATION, BONE

Model Number N/A

Device Problems Unsealed Device Packaging (1444); Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device packaging was not returned however, pictures of complaint device were provided.The analysis of the pictures shows that the sealing side, where the issue occurred, was performed by the supplier of the bag.Analysis of the pictures did not conclude if the seal was not done in this area or if the seal has been achieved and is peeled in this area.The device was packaged by biomet (b)(4) according to pre-defined specifications.According to the data made available, the exact root cause of the event can not be determined.The issue is single.Dhr and complaint history review was performed and no anomalies or trends were found.A summary of the investigation has been sent to the complainant.Risk is addressed in (b)(4) "packaging: non-sterile package and box and label", per section 1.2.2, "non-conformity: packaging material (per qa inspection criteria)".(b)(4).Product location unknown.

Event Description

It was reported that the packaging was opened and the screw was found in the bottom of the box.No further information has been provided.

• Brand Name: CORTICAL SCREW 3.5 X 12MM
• Type of Device: PLATE, FIXATION, 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: 6928152
• MDR Text Key: 89507639
• Report Number: 0001825034-2017-08122
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK111663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• 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: 815037012
• Device Lot Number: M00499 F
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2014
• 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