MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AFFIXUS®CORTICAL BONE SCREW 5.0MM X 48MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number N/A

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

Patient Problem No Patient Involvement (2645)

Event Date 09/03/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4). (udi): n/a. Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. 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 during a surgery, the sterile packaging on product was found to be torn coming out of box and was not used in the surgery. No impact to the patient or surgery was noted.

• Brand Name: AFFIXUS®CORTICAL BONE SCREW 5.0MM X 48MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 9123432
• MDR Text Key: 160194695
• Report Number: 0001825034-2019-04279
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/26/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 814550048
• Device Lot Number: DLNCJN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 12/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2010
• 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