MAUDE Adverse Event Report: ZIMMER SURGICAL SA MOD ELEC/BATT DBL TRIG HP; MOD ELEC/BATT DBL TRIGGER HANDPIECE

Catalog Number 89-8507-400-00

Device Problem Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 01/19/2018

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.

Event Description

It was reported that the modular electronic / battery double trigger handpiece, serial number (b)(4), stopped working.A delay in surgery of more than 30 minutes was reported as the unit used as replacement needed to be sterilize.There is no additional harm or injury to patient/operator reported.The event date in unknown, the notification date is in september 2017.

Manufacturer Narrative

Several attempts were made in effort to retrieve the universal modular electric/battery double trigger handpiece, serial number (b)(4), without success.The device was not returned for complaint investigation.Therefore, it could not be visually inspected in an effort to confirm the defect.Device history record review was performed and no issue was discovered during the manufacturing process that could explain the reported defect.A follow-up medwatch will be submitted if the product is returned or if additional information is received.

• Brand Name: MOD ELEC/BATT DBL TRIG HP
• Type of Device: MOD ELEC/BATT DBL TRIGGER HANDPIECE
• Manufacturer (Section D): ZIMMER SURGICAL SA; 3, ch. du pre fleuri; 1228 plan-les-ouates, geneva CH-12 28; SZ CH-1228
• Manufacturer (Section G): ZIMMER SURGICAL SA; 3, ch. du pre fleuri; 1228 plan-les-ouates, geneva CH-12 28; SZ CH-1228
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6967928
• MDR Text Key: 89915003
• Report Number: 0008031000-2017-00019
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: RW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 5005875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2017
• Initial Date FDA Received: 10/23/2017
• Supplement Dates Manufacturer Received: 10/23/2017; 01/19/2018
• Supplement Dates FDA Received: 10/25/2017; 02/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2015
• 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
• Patient Outcome(s): Other