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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH DEPTH GAUGE FOR MULTILOC HUMERAL NAILING SYSTEM GAUGE,DEPTH

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OBERDORF SYNTHES PRODUKTIONS GMBH DEPTH GAUGE FOR MULTILOC HUMERAL NAILING SYSTEM GAUGE,DEPTH Back to Search Results
Catalog Number 03.019.017
Device Problem Device Fell (4014)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Device received. A review of the device history record has been requested. The investigation could not be completed; no conclusion could be drawn at the time of filing this report. 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) 2019 before using of the device, the tip of the depth gauge has dropped off. There was no patient involvement reported. This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
 
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Brand NameDEPTH GAUGE FOR MULTILOC HUMERAL NAILING SYSTEM
Type of DeviceGAUGE,DEPTH
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
eimattstrasse 3
oberdorf 4436
SZ   4436
6103142063
MDR Report Key8777553
MDR Text Key150616544
Report Number8030965-2019-66138
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
EXEMPT
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 06/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.019.017
Device Lot Number7550906
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/29/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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