MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AFFIXUS HFN 130 DEG 11MM X 180MM; ROD, FIXATION

Model Number N/A

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 07/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see all associated reports: 0001825034-2018-08697, 0001825034-2018-08698, 0001825034-2018-08699.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that while restoring implant tubs in the distributorship, unsterile trauma nails were discovered.The inner sterile packaging was opened inside the wrapped outer box.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

The complaint sample was evaluated and the reported event was confirmed through visual inspection.The returned packaging identified that the inner pouch showed one spot along the sealed area with a void.All other sealed areas were intact.The void made up less than fifty (50) percent of the total sealed area.The device history records were reviewed and no discrepancies were identified.The root cause is determined to be inadequate work procedures/instructions and distribution not being integrated into the company's quality management system.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

No further event information available at the time of this report.

• Brand Name: AFFIXUS HFN 130 DEG 11MM X 180MM
• Type of Device: ROD, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7846674
• MDR Text Key: 119350814
• Report Number: 0001825034-2018-08699
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: PK100238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• 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: 814511180
• Device Lot Number: 244320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1