MAUDE Adverse Event Report: THE ANSPACH EFFORT, INC. ANSPACH DRILL

Device Problems Device Inoperable (1663); Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2018

Event Type  Injury  

Event Description

Anspach drill wouldn't work.Called for another to replace it and both drills in case casts were down for repair with no back up.After several different tries of looking at other service drills nose would be worth for the ear surgery.Called (b)(6) and they sent drill and bars but they didn't fit our motor so they sent their embx motor which worked.Patient experiences prolonged ones this line due to waiting on solution and equipment.No harm to patient.

• Brand Name: ANSPACH DRILL
• Type of Device: DRILL
• Manufacturer (Section D): THE ANSPACH EFFORT, INC.
• MDR Report Key: 7591031
• MDR Text Key: 110935729
• Report Number: MW5077763
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 54 YR
• Patient Weight: 91