MAUDE Adverse Event Report: HALL / CONMED CORPORATION HALL LARGE POWER DRILL; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number L3000LG

Device Problems Device Dislodged or Dislocated (2923); Device Fell (4014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/13/2020

Event Type  Injury  

Event Description

During a total knee replacement, cuts were being made for the implant with a large hall power drill.Approximately 30 mins into the procedure, the seal on the bottom plate of the battery casing became dislodged, causing the concealed lithium battery pack to fall onto the sterile field.Fda safety report id # (b)(4).

• Brand Name: HALL LARGE POWER DRILL
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): HALL / CONMED CORPORATION
• MDR Report Key: 10459277
• MDR Text Key: 204700129
• Report Number: MW5096291
• Device Sequence Number: 1
• Product Code: KIJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: L3000LG
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 60