MAUDE Adverse Event Report: BIOMET 3I TOOL SCR REMOVAL 1.25MM H EX; DENTAL TOOL

Catalog Number SRT

Device Problem Fracture (1260)

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

Event Type  malfunction  

Event Description

It was reported that the screw removal tool (srt) fractured during a procedure to remove a stripped screw.Used another tool to drill through the screw.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).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.

• Brand Name: TOOL SCR REMOVAL 1.25MM H EX
• Type of Device: DENTAL TOOL
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18276614
• MDR Text Key: 330674974
• Report Number: 0001038806-2023-02359
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SRT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2023
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: UNKNOWN BIOMET SCREW AND UNKNOWN BIOMET IMPLANT
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic