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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH DEPTH GAUGE FOR 2.7MM & SMALL SCREWS GAUGE,DEPTH

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OBERDORF SYNTHES PRODUKTIONS GMBH DEPTH GAUGE FOR 2.7MM & SMALL SCREWS GAUGE,DEPTH Back to Search Results
Catalog Number 319.010
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/25/2019
Event Type  malfunction  
Manufacturer Narrative
Additional narrative: the device was received, the investigation is in progress, 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 that on (b)(6) 2019, the patient underwent open reduction internal fixation surgery for distal fibula fracture with the depth gauge in question. During the surgery, the depth gauge didn¿t slide well. It did not work with the saline. Surgery was successful with another dept gauge. There was no surgical delay and no patient consequences. This is report 1 for 1 (b)(4).
 
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Brand NameDEPTH GAUGE FOR 2.7MM & SMALL SCREWS
Type of DeviceGAUGE,DEPTH
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
eimattstrasse 3
oberdorf 4436
SZ   4436
6103142063
MDR Report Key9181218
MDR Text Key191597954
Report Number8030965-2019-69274
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number319.010
Device Lot Number2100618
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/07/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/18/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/07/2004
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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