MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL DRILL; PROSTHESIS, KNEE

Model Number N/A

Device Problems Flaked (1246); Peeled/Delaminated (1454); Mechanical Jam (2983)

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

Event Date 04/25/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Medical product: size d left medial tibial provisional item# 42538100401 lot# 64690747.Articular surface inserter tip item# 42529900301 lot# 65261569.Headed screw 27 mm length item# 00598304027 lot# 65308058.Headed screw 27 mm length item# 00598304027 lot# 64744186.Headed screw 48 mm length item# 00598304048 lot# 65308108.Headless trocar drill pin 3.2 mm diameter 75 mm length item# 00590102000 lot# 65336216.Partial femur cemented size 5 left medial item# 42558000501 lot# 65215930.Partial articular surface left medial size d 8 mm thickness item# 42518200408 lot# 64660795.Partial tibial cemented size d left medial item# 42538000401 lot# 64805141.The product has been returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the tibia peg drill bound up in the tibial plate, producing metal shavings.There is no additional information available.

Event Description

Upon reassessment of this event, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr 0001825034-2022-01746.

Manufacturer Narrative

Upon reassessment of this event, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr 0001825034-2022-01746.

• Brand Name: TIBIAL DRILL
• Type of Device: PROSTHESIS, 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: 14427993
• MDR Text Key: 291982041
• Report Number: 0001822565-2022-01439
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00889024582880
• UDI-Public: (01)00889024582880(10)64719750
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• 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: 42539904900
• Device Lot Number: 64719750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/10/2020
• 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: Male