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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH EXTRACTION SCREW FOR MULTILOC HUMERAL NAILING SYSTEM ROD,FIXATION,INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH EXTRACTION SCREW FOR MULTILOC HUMERAL NAILING SYSTEM ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 03.019.024
Device Problem Device-Device Incompatibility (2919)
Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Event Date 01/23/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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 (b)(6) 2020 during an unknown medical device removal that the connection screw for removal of multiloc nail didn¿t really fit in the thread, so they had to use another one from an other system. The surgery was prolonged by 40 minutes. The procedure was completed successfully. This complaint involves one (1) device. This is 1 of 1 for report (b)(4).
 
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Brand NameEXTRACTION SCREW FOR MULTILOC HUMERAL NAILING SYSTEM
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, PA 19380
6107195000
MDR Report Key9711488
MDR Text Key191450056
Report Number8030965-2020-01137
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K120807
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 01/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.019.024
Device Lot Number9789885
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/06/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/09/2016
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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