MAUDE Adverse Event Report: ZIMMER SURGICAL S.A. UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE; UNIVERSAL MODULAR/ELECTRIC/BATTERY DOUBLE

Catalog Number 89-8507-400-00

Device Problems Loss of Power (1475); Connection Problem (2900)

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

Event Date 01/21/2014

Event Type  malfunction  

Event Description

It was reported that during the surgery, first drill is attached to the universal modular electric/battery double trigger handpiece.When it was connected with the bone, it stopped.Although the battery was changed, it did not work.Surgery was delayed by forty five minutes, and there was no patient harm.

Manufacturer Narrative

The device was not returned to the manufacturer at the time of this report.A follow up medwatch will be submitted once the device has been returned and the investigation is complete.

• Brand Name: UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE
• Type of Device: UNIVERSAL MODULAR/ELECTRIC/BATTERY DOUBLE
• Manufacturer (Section D): ZIMMER SURGICAL S.A.; chemin pre fleuri 3, plan les ouates; geneva CH-1 228; SZ CH-1228
• Manufacturer Contact: kathleen smith ; chemin pre fleuri 3, plan les ouates; geneva CH-12-28 ; SZ CH-1228 ; 3438801
• MDR Report Key: 3834692
• MDR Text Key: 15180510
• Report Number: 8031000-2014-00178
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 89-8507-400-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2014
• Was Device Evaluated by Manufacturer?: No
• 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