• 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 Mechanical Problem (1384); Vibration (1674)
Patient Problem No Information (3190)
Event Date 10/15/2019
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 submitted once the investigation is completed or if additional information is received.

 
Event Description

It was reported that the oscillating saw attachment part number 89-8509-450-60 serial number (b)(4) stopped during knee arthroplasty (cutting distal femur). The saw was shaking before stopping and the surgeon cut the veins of the patient which resulted in a loss of blood. The surgery was extended for 5 minutes to fix the cut and transfusion was required. There was no other harm reported to the patient/user.

 
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 Key9327528
MDR Text Key166556124
Report Number0008031000-2019-00021
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeTH
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 01/27/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/15/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number89-8509-450-60
Device LOT Number5004066
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/04/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/13/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/13/2014
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: 11/15/2019 Patient Sequence Number: 1
-
-