MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 5° CAPTURED LEFT MEDIAL TIBIAL CUT GUIDE DO NOT IMPLANT; PROSTHESIS, KNEE

Model Number N/A

Device Problems Fracture (1260); Material Fragmentation (1261); Mechanical Jam (2983)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/25/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: switzerland.Concomitant medical products: product id: 00590102000, product type: headless trocar drill pin 3.2 mm diameter 75 mm length, lot: 65403154.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 was reported that when fixing the relevant tibial cutting block with the pin, metal debris formed.There was no surgical delay.The surgical technique was utilized.The surgery was not completed with a second device.The metal debris did fall into the patient and staff were not sure if all of the pieces had been retrieved.No post-op imaging was taken to confirm if metal debris were retained.Attempts have been made and all available information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Upon reassessment of the reported event, it was determined to be not reportable as no serious injury or harm to the patient was reported for this event or prior events with same or similar products.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: 5° CAPTURED LEFT MEDIAL TIBIAL CUT GUIDE DO NOT IMPLANT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16310917
• MDR Text Key: 308922047
• Report Number: 0001822565-2023-00309
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00880304809086
• UDI-Public: (01)00880304809086(10)63735849
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K200151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• 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: 42539905185
• Device Lot Number: 63735849
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Sex: Female