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

Catalog Number 89-8507-400-00

Device Problems Partial Blockage (1065); Device Inoperable (1663)

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

Event Date 02/20/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the manufacturer at the date of this report.A follow-up medwatch will be submitted once the investigation is completed or if additional information is received.

Event Description

It was reported that the universal modular electric/battery double trigger handpiece 89-8507-400-00, serial number (b)(4) was blocked and not functional.The surgery delay was 75 minutes and the patient was under anesthesia.The reason of the delay was the time to search another device.Additional anesthesia was prescribed.There was no additional harm or injury to patient/operator reported.

Event Description

It was reported that the universal modular electric/battery double trigger handpiece 89-8507-400-00, serial number (b)(4) was blocked and not functional.The surgery delay was 75 minutes and the patient was under anesthesia.The surgery was a total knee replacement.The reason of the delay was the time to search another device.Additional anesthesia was prescribed.There was no additional harm or injury to patient/operator reported.

Manufacturer Narrative

Universal modular electric/battery double trigger handpiece serial number (b)(4) was returned for complaint investigation.Visual and functional tests were performed.Upon receipt, it was confirmed that the motor screw was broken and the locking system between the attachment and the handpiece was defective.A possible misuse was detected as some wires were modified.The event reported by the customer (bloqued & not functional) was confirmed.Following the instructions of the customer, the device was returned unrepaired with a discharge letter.

• Brand Name: UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE
• Type of Device: UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE
• Manufacturer (Section D): ZIMMER SURGICAL SA; chemin du pre fleuri, 3; plan-les-ouates, geneva CH-12 28; SZ CH-1228
• MDR Report Key: 7376539
• MDR Text Key: 103649782
• Report Number: 0008031000-2018-00015
• 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,Followup
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• 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: 5007135
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 67