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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 Overheating of Device (1437); Noise, Audible (3273)
Patient Problem No Code Available (3191)
Event Date 12/07/2016
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.

 
Event Description

It was reported that the universal oscillating saw attachment overheated and had a high level of noise. The surgery delay was 2 hours. The surgery was completed with another device. There was no additional harm or injury to patient/operator reported.

 
Manufacturer Narrative

Several attempts were made in effort to retrieve the universal oscillating saw attachment, serial number (b)(4), without success. The device was not returned for complaint investigation. Therefore, it could not be visually inspected in an effort to confirm the defect. Device history record review was performed and no issue was discovered during the manufacturing process that could explain the defect reported. A follow-up medwatch will be submitted if the product is returned or if additional information is received.

 
Event Description

It was reported that the universal oscillating saw attachment overheated and had a high level of noise. The surgery delay was 2 hours. The surgery was completed with another device. There was no additional harm or injury to patient/operator reported. New information received on may 1st 2017: the customer cleaned the modular electric/battery single trigger handpiece serial number (b)(4) and the oscillating saw attachment serial number (b)(4) with reverse osmosis water and betadine scrub. After drying, the customer used 2 or 3 drops of synthes synthetic oil on the oscillating saw attachment which is considered as abnormal use. Then, they sterilized the device.

 
Manufacturer Narrative

Several attempts were made in effort to retrieve the universal oscillating saw attachment, serial number (b)(4), without success. The device was not returned for complaint investigation. Therefore, it could not be visually inspected in an effort to confirm the defect. Device history record review was performed and no issue was discovered during the manufacturing process that could explain the defect reported. Additional information was received: a backup device was used to complete the surgery and the reason of the delay was the time needed to prepare it. A follow-up medwatch will be submitted if the product is returned or if additional information is received.

 
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Brand NameOSCILLATING SAW ATTACHMENT
Type of DeviceOSCILLATING SAW ATTACHMENT
Manufacturer (Section D)
ZIMMER SURGICAL SA
chemin du pre fleuri, 3
plan-les-ouates, geneva CH-12 28
SZ CH-1228
Manufacturer (Section G)
ZIMMER SURGICAL SA
chemin du pre fleuri 3
plan-les-ouates, geneva CH-12 28
SZ CH-1228
Manufacturer Contact
christina arnt
56 e. bell drive
warsaw, IN 46582
5745273773
MDR Report Key6236074
MDR Text Key64249751
Report Number0008031000-2017-00002
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 08/03/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/10/2017
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 Number5005550
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/11/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/08/2014
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: 01/10/2017 Patient Sequence Number: 1
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