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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES OBERDORF OSCILL-SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

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SYNTHES OBERDORF OSCILL-SAW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 518.010
Device Problem Fire (1245)
Patient Problem Partial thickness (Second Degree) Burn (2694)
Event Date 04/04/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). (b)(6). The actual device has been returned and is currently pending evaluation. Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported from (b)(6) that during an unspecified surgery, just after sawing, it was observed that the saw attachment device had fire coming out of the handpiece device. It was further reported that the fire coming out of the device was a "wok fire (really huge and hot)¿. According to the report, the attachment device was in use with two double air hose devices at the time of the event. There was no alleged malfunction against the double air hose devices. There was patient involvement reported. It was reported that the patient had superficial first and second degree burns on an area of 8 x 5 centimeters. It was further reported that there was a second degree burn to the patient's shoulder. It was reported that the patient¿s burn was treated with flamacin and urget-01 (a special kind of creamy fat pads). The patient¿s post-operative condition was not provided. It was reported that there was a fifteen minute delay to the surgical procedure. It was reported that a spare device was available for use in order to successfully complete the surgery. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
Manufacturer Narrative
This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment. During repair, it was determined that the device failure reported could not be re-produced and there were no visible burns or heat traces at the saw were visible. During the evaluation, it was determined that the motor power was too low and the hose was brittle and overstretched. The assignable root cause was determined to be due to wear from normal use and servicing. If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
Manufacturer Narrative
Additional information. During subsequent follow up with the reporter that during the procedure it was reported that medical compressed air was being used to propel the device and not oxygen. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Type of reportable event: upon complaint review, it was determined that the type of reportable event was incorrectly categorized as a malfunction in the initial report. This is a serious injury complaint and the type of reportable event has been updated accordingly to reflect this information. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand NameOSCILL-SAW
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
Manufacturer (Section D)
SYNTHES OBERDORF
eimattstrasse 3
oberdorf CH443 6
SZ CH4436
Manufacturer (Section G)
SYNTHES OBERDORF
eimattstrasse 3
oberdorf CH443 6
SZ CH4436
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6520640
MDR Text Key73643416
Report Number8030965-2017-12001
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K971544
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 04/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number518.010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/10/2014
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: 04/25/2017 Patient Sequence Number: 1
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