• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER SURGICAL SA UNIVERSAL MODULAR ELECTRIC/BATTERY SINGLE TRIGGER HANDPIECE Back to Search Results
Catalog Number 89-8507-400-10
Device Problems Mechanical Problem (1384); Unexpected Shutdown (4019)
Patient Problem Insufficient Information (4580)
Event Date 01/07/2021
Event Type  Injury  
Manufacturer Narrative
Complaint number cmp (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) stopped. The event occurred during surgery. An extension of surgery of 120 minutes was reported due to the time needed to sterilize the standby handpiece. There was no additional harm or injury to patient/operator reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNIVERSAL MODULAR ELECTRIC/BATTERY SINGLE TRIGGER HANDPIECE
Type of DeviceUNIVERSAL MODULAR ELECTRIC/BATTERY SINGLE TRIGGER 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, geneva 1228
SZ 1228
Manufacturer Contact
christina arnt
56 e. bell drive
warsaw, IN 46582
5745273773
MDR Report Key11397524
MDR Text Key234207917
Report Number0008031000-2021-00004
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number89-8507-400-10
Device Lot Number5008309
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/26/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/16/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/02/2021 Patient Sequence Number: 1
-
-