MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CAPTURED LEFT MEDIAL TIBIAL CUT GUIDE; INSTRUMENT, KNEE

Model Number 42-5399-051-85

Device Problem Mechanical Jam (2983)

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

Event Date 10/21/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical product: headless trocar drill pin 75mm: catalog#00590102000; lot#65003961.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-03343.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.

Event Description

It was reported that during an initial left knee procedure, the drill pin cold welded into the tibial block.The surgeon was able to remove the cutting block without additional intervention, surgical delay, or patient impact.The pin fractured after surgery when trying to remove it from the block.

Event Description

See h10 narrative.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Upon receipt of additional information, it was determined that this product should not have been reported under this mfr number.This initial report should be voided and a corrected report has been filed under mdr number: 0001825034-2022-00517.

• Brand Name: CAPTURED LEFT MEDIAL TIBIAL CUT GUIDE
• Type of Device: INSTRUMENT, KNEE
• 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: 12856761
• MDR Text Key: 281219349
• Report Number: 0001822565-2021-03342
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00880304809086
• UDI-Public: (01)00880304809086(10)64507371
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42-5399-051-85
• Device Catalogue Number: 42539905185
• Device Lot Number: 64507371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/23/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Sex: Male