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

Model Number N/A

Device Problem Failure to Shut Off (2939)

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

Event Date 05/22/2015

Event Type  malfunction  

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 is returned and investigation is complete.

Event Description

It is reported that the universal modular electric/battery double trigger handpiece has motor which worked continuously without stopping.There was no patient harm reported.A delay in surgery less than 15 minutes was reported.

Manufacturer Narrative

The device was not returned to the manufacturer for complaint investigation.The defect could then not be confirmed.No issue has been found in the manufacturing process which could explain the reported event.A medwatch follow-up will be submitted if the device is eventually returned to the manufacturer.

• Brand Name: UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE
• Type of Device: UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE
• Manufacturer (Section D): ZIMMER SURGICAL S.A.; chemin pre fleuri 3; plan les ouates, geneva CH-12 28; SZ CH-1228
• Manufacturer Contact: cécile guiot ; chemin pre fleuri 3; plan les ouates, geneva CH-12-28 ; SZ CH-1228 ; 7062106
• MDR Report Key: 4987901
• MDR Text Key: 22442476
• Report Number: 8031000-2015-00096
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: IR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 10/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 89-8507-400-00
• Device Lot Number: 5002619
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/04/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/06/2012
• 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