MAUDE Adverse Event Report: W&H ZIMMER MOTOR SYSTEM 115V

Catalog Number 00900125

Device Problem Mechanical Problem (1384)

Patient Problem No Information (3190)

Event Date 11/02/2017

Event Type  Injury  

Event Description

It was reported that the 00900125 motor stopped working and was over heating during a procedure.The patient's surgical site was closed up and the patient left without an implant placed.

• Brand Name: ZIMMER MOTOR SYSTEM 115V
• Type of Device: MOTOR SYSTEM
• Manufacturer (Section D): W&H; ignaz-glaser-strasse 53; postfach 1; bürmoos 5111 ; AU 5111
• MDR Report Key: 7068998
• MDR Text Key: 93291745
• Report Number: 0001038806-2017-00844
• Device Sequence Number: 1
• Product Code: EBW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 11/10/2017,11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00900125
• Device Lot Number: SN 06296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/02/2017
• Event Location: Other
• Date Report to Manufacturer: 11/10/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention