MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SPDPASS LARIAT W/NIT 45DEG UP; PASSER

Model Number N/A

Device Problems Unsealed Device Packaging (1444); Out-Of-Box Failure (2311); Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2015

Event Type  malfunction  

Manufacturer Narrative

The complaint was confirmed in that the bottom biomet seal had been peeled open.Presence of adhesive transfer as well as the requirements of inspection criteria lead to the assumption that the peeling of the seal occurred after the product left biomet's control, although it cannot be determined.The coob summary in the complaint and review of other parts from the same lot indicate that the 2 parts with the peeled open seal are part of an isolated incident.Review of the complaint history identified an issue that was investigated, and it was determined that no further action is required due to the two complaints were isolated incidents.Review of device history records found these units were released to distribution with no deviations or anomalies.A summary of the investigation has been 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.This report is being submitted late as it has been identified in remediation.

Event Description

It was reported that the sterile packaging inside of box was not sealed properly.The outer packaging, including dust cover, was intact prior to opening.There was no delay or patient injury.This was not a revision.

• Brand Name: SPDPASS LARIAT W/NIT 45DEG UP
• Type of Device: PASSER
• 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: 6940810
• MDR Text Key: 90303480
• Report Number: 0001825034-2017-08469
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2018
• Device Model Number: N/A
• Device Catalogue Number: 904008
• Device Lot Number: 961030
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2013
• 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