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

Catalog Number 89-8507-400-00

Device Problem Failure to Power Up (1476)

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

Event Date 06/02/2015

Event Type  malfunction  

Event Description

It was reported that the universal modular electric/battery double trigger handpiece, sn (b)(4), fails to run.The surgery was extended for 1 hr.No pt harm was reported.

Manufacturer Narrative

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

Manufacturer Narrative

Universal modular electric/battery double trigger handpiece, serial number (b)(4), has been returned for complaint investigation.Upon receipt, it has been confirmed that the handpiece worked intermittently due to defective motor and that the trigger/controller boards wire was defective.The motor, the aforementioned wire and seals have been replaced.The product has been returned to the customer.

• Brand Name: UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE T
• Type of Device: UNIVERSAL MODULAR ELECTRIC/BATTERY DOUB
• Manufacturer (Section D): ZIMMER SURGICAL S.A.; chemin pre fleuri 3; plan les quates, geneva CH - 1228
• Manufacturer Contact: cecile guiot ; chem pre fleuri 3; plan les quates, geneva CH-12-28 ; 27062106
• MDR Report Key: 4874255
• MDR Text Key: 5860385
• Report Number: 8031000-2015-00078
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2015
• 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
• Device Lot Number: 5005317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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