MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MG II BONE SCREW DRILL 3.2MM DIAMETER; INSTRUMENT, KNEE

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 12/06/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complainant 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 during knee arthroplasty that the bone screw drill fractured while the surgeon was drilling tibial rotation holes.The broken drill was retrieved from the patient's bone and no adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6 - component code - proposed code is mechanical (g04) - drill.Visual evaluation of the returned device identified signs of repeated use (nicked/gouged) and the device was fractured.The device history records were reviewed and no discrepancies were identified.As the device has a potential field age of over 9 years and exhibits signs of repeated use, the root cause is attributed to wear and tear from repeated use over time.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: MG II BONE SCREW DRILL 3.2MM DIAMETER
• Type of Device: INSTRUMENT, 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: 18400513
• MDR Text Key: 331418495
• Report Number: 0001822565-2023-03793
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• 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: 00512008500
• Device Lot Number: 62678892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose