MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FIB ANATOMIC LOCK LEFT 4H STE; FIXATION, BONE

Catalog Number 856206004

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 03/04/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).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 has been reported that the inspection member found a channel on the sterile package.There was no patient involvement or harm caused as a result of this event.

Event Description

No additional event information is available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d10, g4, g7, h1, h2, h3, h6, h10 complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned product found a channel/crease that runs along the full width of the seal.The product was sent for further testing.Testing indicates the compromised seal passed the pressurized seal integrity test.Sterility has not been compromised.Device history record (dhr) was reviewed and no discrepancies were found.These products were likely non-conforming when they left zimmer biomet control.The root cause of the reported event can be attributed to the operator not following instructions during manufacturing.A corrective action has been initiated to further address the reported issue.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.

• Brand Name: FIB ANATOMIC LOCK LEFT 4H STE
• Type of Device: FIXATION, BONE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9877907
• MDR Text Key: 188872467
• Report Number: 0001825034-2020-01093
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K111663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 856206004
• Device Lot Number: 846030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1