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

Model Number	42-5399-051-85
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem Description
See h10 narrative.
Additional 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
• Common Device Name: 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
• Report Number: 0001822565-2021-03342
• Device Sequence Number: 5082204
• Product Code: HSX
• UDI-Device Identifier: 00880304809086
• UDI-Public: (01)00880304809086(10)64507371
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K200151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2021
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Patient Sex: Male