MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FIB ANATOMIC LOCK RT 6H STE; PLATE, FIXATION

Model Number N/A

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign source: japan.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 -02411.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.

Event Description

It was reported that the product was received and the sterile package was not vacuum sealed.There was no patient involvement.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d10, g3, g7, h1, h2, h3, h6, h10 evaluation of the returned product found the packaging meets the standards of inspection criteria.No product failure was found as the products are within specifications.No further investigation or action is required after review.As no product failure was found, this complaint will be deemed not reportable.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: FIB ANATOMIC LOCK RT 6H STE
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15665692
• MDR Text Key: 302337314
• Report Number: 0001825034-2022-02412
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00887868446009
• UDI-Public: (01)00887868446009(17)320730(10)888500
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• 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: 856207006
• Device Lot Number: 888500
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/17/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1