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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CONNECTING SCREW/CANNULATED FOR MULTILOC HUMERAL NAIL ROD,FIXATION,INTRAMEDULLARY
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OBERDORF SYNTHES PRODUKTIONS GMBH CONNECTING SCREW/CANNULATED FOR MULTILOC HUMERAL NAIL ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 03.019.007
Device Problem Crack (1135)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Reporter is a synthes employee. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. Device is not distributed in the united states but is similar to device marketed in the usa. 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 on an unknown date that during inspection of rental set t01249, a metal coil was discovered in the tool 03. 019. 007 in the area of the internal thread. Presumably, it is part of the internal thread. The kit was issued for a demonstration training course on plastic bones. There were no surgery or patient involved. This is report 1 of 1 for (b)(4).
 
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Brand NameCONNECTING SCREW/CANNULATED FOR MULTILOC HUMERAL NAIL
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK HÄGENDORF (CH)
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester 19380
6103142063
MDR Report Key9482801
MDR Text Key195658478
Report Number8030965-2019-71161
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeRS
PMA/PMN Number
K103002
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
Report Date 11/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.019.007
Device Lot Number1L47786
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/17/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/13/2018
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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