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

Catalog Number 89-8507-400-00

Device Problem Failure to Shut Off (2939)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2014

Event Type  malfunction  

Event Description

It is reported that it is not possible to turn off the universal modular electric/battery double trigger handpiece.There was no pt harm or delay reported.

Manufacturer Narrative

The device was returned to the mfr; however, the investigation was not completed at the time of this report.A follow up medwatch will be submitted once the investigation is complete.

• Brand Name: UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE T
• 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
• Manufacturer Contact: kathleen smith ; chemin pre fleuri 3; plan les ouates, geneva CH-12-28 ; 3438801
• MDR Report Key: 3995266
• MDR Text Key: 4960054
• Report Number: 8031000-2014-00266
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: EZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2014
• 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
• Date Returned to Manufacturer: 04/22/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1