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

Catalog Number 89-8507-400-10

Device Problems Complete Blockage (1094); Failure to Auto Stop (2938)

Patient Problem No Information (3190)

Event Date 11/12/2020

Event Type  Injury  

Manufacturer Narrative

Complaint number (b)(4). The device was not returned to the manufacturer at the date of this report. A follow-up medwatch will be sent if the product is returned or if additional information is received.

Event Description

It was reported that the universal modular electric/battery single trigger handpiece part number 89-8507-400-10 serial number (b)(4) does not stop, the trigger is blocked. The event occurred during surgery. An extension of surgery of 60 minutes was reported due to the time needed to replace the device. There was no additional harm or injury to patient/operator reported.

• Brand Name: UNIVERSAL MODULAR ELECTRIC/BATTERY SINGLE TRIGGER HANDPIECE
• Type of Device: UNIVERSAL MODULAR ELECTRIC/BATTERY SINGLETRIGGER HANDPIECE
• Manufacturer (Section D): ZIMMER SURGICAL SA; 3, ch. du pre fleuri; plan-les-ouates, geneva 1228 ; SZ 1228
• Manufacturer (Section G): ZIMMER SURGICAL SA; 3, ch. du pre fleuri; plan-les-ouates; plan-les-ouates, geneva 1228 ; SZ 1228
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 10913793
• MDR Text Key: 218510881
• Report Number: 0008031000-2020-00010
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (Y/N): N
• Reporter Country Code: KE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/27/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 11/27/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: 89-8507-400-10
• Device LOT Number: 5008029
• Was Device Available For Evaluation?: No

Is The Reporter A Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 11/13/2020
• Was Device Evaluated By Manufacturer?: No
• Date Device Manufactured: 04/12/2016
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient TREATMENT DATA

Date Received: 11/27/2020 Patient Sequence Number: 1