MAUDE Adverse Event Report: ZIMMER SURGICAL SA MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE

Catalog Number 89-8507-400-00

Device Problem Device Inoperable (1663)

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

Event Date 05/08/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the manufacturer at the date of this report.The complaint was initially reported by (b)(6).No additional contact information were received from initial reporter.A follow-up medwatch will be submitted once the investigation is completed or new information is available.

Event Description

It was reported that the modular electric/battery double trigger handpiece serial number (b)(4) stopped when high torque was needed.The surgery delay is unknown.There was no harm or injury to patient/operator reported.

Manufacturer Narrative

Information received on 6th of june 2018 from (b)(6) that the delay of the surgery was 2 min and that no additional anesthesia was used.Therefore this complaint is not reportable any longer.

• Brand Name: MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE
• Type of Device: MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE
• Manufacturer (Section D): ZIMMER SURGICAL SA; chemin du pre fleuri, 3; plan-les-ouates, geneva 1228 ; SZ 1228
• MDR Report Key: 7568562
• MDR Text Key: 110046036
• Report Number: 0008031000-2018-00017
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 89-8507-400-00
• Device Lot Number: 5002424
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other