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

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 04/07/2021

Event Type  malfunction  

Event Description

Long footplate from anspach® xmax® drill high speed pneumatic system broke into 2 pieces during an bone-related surgical procedure.Two broken parts sequestered, surgical site examined extensively, no other fragment found.Two broke parts fit perfectly when put together.Surgical site irrigated copiously with sterile saline, surgical site reexamined.Continuous and final x-ray shots taken, prior to closing.Results read and approved by surgeon who concluded absent of foreign body.Broke anspach® pneumatic long footplate forwarded to nurse manager.

• 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: 11782827
• MDR Text Key: 249232228
• Report Number: 11782827
• 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: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• 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: 04/28/2021
• Date Report to Manufacturer: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 9125 DA