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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SLIDING CARRIAGE TRACTION,APPARATUS,NON-POWERED

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OBERDORF SYNTHES PRODUKTIONS GMBH SLIDING CARRIAGE TRACTION,APPARATUS,NON-POWERED Back to Search Results
Catalog Number 394.430
Device Problem Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. A review of the device history records has been requested. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, a femoral distractor was used during an unknown procedure. While being used, the surgeon noticed that the serrated edge on the sliding carriage was worn which created potential for the device to slip. The surgeon ensured that the bolt was tightened and continued to use the device without issue. The surgery was successfully completed with no surgical delay. Patient status is unknown. This report is for one (1) sliding carriage. This is report 1 of 1 for (b)(4).
 
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Brand NameSLIDING CARRIAGE
Type of DeviceTRACTION,APPARATUS,NON-POWERED
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ 2544
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6103142063
MDR Report Key8071487
MDR Text Key127409519
Report Number8030965-2018-58226
Device Sequence Number1
Product Code HST
Combination Product (y/n)N
Reporter Country CodeNZ
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 10/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number394.430
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 Received01/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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