MAUDE Adverse Event Report: BIOMET MICROFIXATION BIOMET MICRCROFIXATION LITHIUM BATTERY; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Model Number 72-1010

Device Problems Melted (1385); Material Rupture (1546); Battery Problem (2885); Chemical Problem (2893); Noise, Audible (3273)

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

Event Date 03/27/2023

Event Type  malfunction  

Event Description

The biomet battery w/ drill was never used on the patient.Surgical tech tried to remove the biomet battery from the handpiece when he was breaking down the instruments.He noticed that it was hard to separate the battery from the drill as the locking mechanism was engaged.He was able to remove the battery with a hard pull.The tech could feel the battery expand in his gloved hand and he heard a pop.He then placed the battery is a basin and placed a damp surgical towel over the battery.He checked his gloved hand and no damage to the glove occurred.There was no heat emitted from the battery.Once in the basin the battery emitted a particle/dust cloud.The basin was pushed out of the operating room into the hallway.Per the fire department's recommendation, water was poured over the battery.No harm to patient or operating room team occurred.Unable to test the damaged battery and it was disposed of versus being sequestered.No tests have been completed on the lithium battery as it is melted.

• Brand Name: BIOMET MICRCROFIXATION LITHIUM BATTERY
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): BIOMET MICROFIXATION; jacksonville FL 32218
• MDR Report Key: 16673805
• MDR Text Key: 312692557
• Report Number: MW5116247
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 72-1010
• Device Catalogue Number: 72-1000
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Sex: Female
• Patient Weight: 44 KG
• Patient Ethnicity: Hispanic