MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DIST TIB ANTLAT R NRW 12H STE; PLATE, FIXATION, BONE

Model Number N/A

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 10/28/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source foreign: japan.Concomitant medical products: dist tib antlat r nrw 12h ste cat#856202012 lot#475930 ; qty: 3 total, lock dist tib med lt 9h ste cat# 856211009 lot# 762010 qty: 3 total.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 02519, 0001825034 - 2022 - 02520, 0001825034 - 2022 - 02522, 0001825034 - 2022 - 02523, 0001825034 - 2022 - 02524.

Event Description

It was reported during an incoming inspection that the sterile package was not vacuum sealed.Additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product failure was found as the products are within specifications.No further investigation or action is required after review.This complaint cannot be confirmed as the product was found to be conforming.Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.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: DIST TIB ANTLAT R NRW 12H STE
• Type of Device: PLATE, FIXATION, BONE
• 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: 15839273
• MDR Text Key: 307666614
• Report Number: 0001825034-2022-02521
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00887868449659
• UDI-Public: (01)00887868449659(17)321006(10)475930
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• 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: 856202012
• Device Lot Number: 475930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2022
• 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