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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC SAGITTAL SAW ATTACHMENT FOR TRS INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

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DEPUY SYNTHES PRODUCTS LLC SAGITTAL SAW ATTACHMENT FOR TRS INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Model Number 05.001.223
Device Problem Device Inoperable (1663)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/20/2018
Event Type  malfunction  
Manufacturer Narrative
Reporter's facility name, complete address and phone number were not provided. The actual device has been returned and is currently pending evaluation. Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.
 
Event Description
This is event 2 of 2 of the same event. It was reported from (b)(6) that during an attune knee prosthesis surgery, it was observed that the procedure started without problem, however as the surgery continued, the power module device and saw adapter device began to fail. It was reported that the surgery was prolonged for approximately one hour while spare devices were being retrieved. It was further reported that the surgeon continued the surgery and finished the operation manually without further problems; no revision surgery was necessary. It was reported that the patient¿s post-operative status was stable. There were no injuries, medical intervention or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
Manufacturer Narrative
The actual device was returned for evaluation. Reliability engineering evaluated the device and determined that the device passed all manufacturing specifications and identified no failure. Therefore, the reported condition was not confirmed and an assignable root cause was not determined. If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
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Brand NameSAGITTAL SAW ATTACHMENT FOR TRS
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
Manufacturer (Section D)
DEPUY SYNTHES PRODUCTS LLC
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7427722
MDR Text Key105401821
Report Number8030965-2018-53068
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodePE
PMA/PMN Number
EXEMPT
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
Report Date 03/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number05.001.223
Device Catalogue Number05.001.223
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/28/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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