MAUDE Adverse Event Report: THE ANSPACH EFFORT, INC.; DRILLS, BURRS, TREPHINES ACCESSORIES (SIMPLE, POWERED)

Device Problem Break (1069)

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

Event Date 07/10/2019

Event Type  malfunction  

Event Description

X-max side cutter drill piece was used on patient's skull.During cutting of skull, side cutter's tip broke and fell into patient's dura.Side cutter and broken piece was retrieved and passed off sterile field.Offered x-ray at end of case and physician declined.

• Brand Name: NA
• Type of Device: DRILLS, BURRS, TREPHINES ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): THE ANSPACH EFFORT, INC.; 4500 riverside dr.; palm beach gardens FL 33410
• MDR Report Key: 9763212
• MDR Text Key: 181157635
• Report Number: 9763212
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/21/2020,12/26/2019

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/21/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/27/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Weight: 70