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

Model Number	L-8NS-M-C-G1
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The anspach drill bit had the tip break off.The tip was seen on x-ray and required removal during surgery.

• Brand Name: NA
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): THE ANSPACH EFFORT, INC.; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9494834
• Report Number: 9494834
• Device Sequence Number: 259100
• Product Code: HBE
• UDI-Device Identifier: 00845384013105
• UDI-Public: (01)00845384013105
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2019
• Report Date (Section F): 12/06/2019

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
• Operator of Device: Health Professional
• Device Model Number: L-8NS-M-C-G1
• Device Catalogue Number: L-8NS-M-C-G1
• Device Lot Number: N153136822
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 128
• Date Report Sent to FDA: 12/06/2019