• 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 OSCILLATING SAW ATTACHMENT

  • 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 OSCILLATING SAW ATTACHMENT Back to Search Results
Catalog Number 89-8509-450-60
Device Problems Activation, Positioning or SeparationProblem (2906); Detachment of Device or Device Component (2907); Knife (3156)
Patient Problems No Information (3190); No Code Available (3191)
Event Date 07/10/2018
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 any additional information is received.

 
Event Description

It was reported that the oscillating saw attachment part number 89-8509-450-60, serial number (b)(4), failed to hold the blade during osteotomy. The surgery delay was 45 minutes due to the time needed to sterilize another device to complete the surgery. There was no additional harm or injury to patient/operator reported.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameOSCILLATING SAW ATTACHMENT
Type of DeviceOSCILLATING SAW ATTACHMENT
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 Key7804317
MDR Text Key117835804
Report Number0008031000-2018-00022
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeKE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/30/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/22/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number89-8509-450-60
Device LOT Number5005954
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/24/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/05/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 08/22/2018 Patient Sequence Number: 1
-
-