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

Catalog Number 00900125

Device Problems Mechanical Problem (1384); Overheating of Device (1437); Device Operates Differently Than Expected (2913)

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

Event Date 11/02/2017

Event Type  malfunction  

Manufacturer Narrative

The device has been returned to the manufacturer w&h and will be analysed and a follow-up report will sent to fda afterwards.

Event Description

It was reportet that the (b)(4) 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 DENTALWERK BUERMOOS GMBH; ignaz-glaser-strasse 53; buermoos, 5111 ; AU 5111
• Manufacturer (Section G): W&H DENTALWERK B[?]RMOOS GMBH; ignaz-glaser-stra[?]e 53; b[?]rmoos, salzburg 5111 ; AU 5111
• Manufacturer Contact: anja lindner ; ignaz-glaser-strasse 53; buermoos, salzburg 5111 ; AU 5111
• MDR Report Key: 7116337
• MDR Text Key: 95667044
• Report Number: 9681479-2017-00006
• Device Sequence Number: 1
• Product Code: EBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00900125
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention