MAUDE Adverse Event Report: BIOMET MICROFIXATION, INC N/A; ELEVATOR, SURGICAL, DENTAL

Model Number 09-0257

Device Problem Break (1069)

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

Event Date 08/31/2021

Event Type  malfunction  

Event Description

The device was used for dental extraction procedure for the patient.Following extraction of teeth #1,16,32 it was noted that the small straight elevator was chipped at the working end, about 1mm in size, was missing.The surgical sites were irrigated well, suctioned, and explored.There was no point in the case where force was applied to the instrument such that it would create a chip in the instrument or any point when it was heard/felt to chip.Likely the instrument came that way from spd and a safety post will be completed regardless.Due to small size, less than 2mm, no x ray was taken, and this was discussed among the or team and agreed upon.Discussed with patient family.

• Brand Name: N/A
• Type of Device: ELEVATOR, SURGICAL, DENTAL
• Manufacturer (Section D): BIOMET MICROFIXATION, INC; 56 east bell drive; warsaw IN 46581
• MDR Report Key: 12567769
• MDR Text Key: 274469742
• Report Number: 12567769
• Device Sequence Number: 1
• Product Code: EMJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/21/2021

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
• Device Operator: Health Professional
• Device Model Number: 09-0257
• Device Catalogue Number: 09-0257
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/21/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 5840 DA
• Patient Weight: 44