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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL SA OSCILLATING SAW ATTACHMENT

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ZIMMER SURGICAL SA OSCILLATING SAW ATTACHMENT Back to Search Results
Catalog Number 89-8509-450-60
Device Problems Mechanical Problem (1384); Device Slipped (1584); Activation, Positioning or SeparationProblem (2906); Device Subassembly (3051)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 07/15/2018
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 saw blade in place during osteotomy. The surgery delay was 45 minutes due to the time needed to sterilize another product to complete the surgery. There was no additional harm or injury to patient / operator reported.

 
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Brand NameOSCILLATING SAW ATTACHMENT
Type of DeviceOSCILLATING SAW ATTACHMENT
Manufacturer (Section D)
ZIMMER SURGICAL SA
3, ch. du pre fleuri
geneva 1228
SZ 1228
Manufacturer (Section G)
ZIMMER SURGICAL SA
3, ch. du pre fleuri
geneva 1228
SZ 1228
Manufacturer Contact
christina arnt
56 e. bell drive
warsaw, IN 46582
5745273773
MDR Report Key7804475
MDR Text Key117846579
Report Number0008031000-2018-00023
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,Followup,Followup
Report Date 07/31/2019
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? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number89-8509-450-60
Device LOT Number5006777
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/16/2018
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? Yes
Date Device Manufactured07/13/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

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