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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PLATE CUTTER/IN-LINE FOR 1.3MM LCKNG/1.5-2.0MM VAL PL PLIERS,SURGICAL

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OBERDORF SYNTHES PRODUKTIONS GMBH PLATE CUTTER/IN-LINE FOR 1.3MM LCKNG/1.5-2.0MM VAL PL PLIERS,SURGICAL Back to Search Results
Catalog Number 03.130.270
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/26/2019
Event Type  Malfunction  
Manufacturer 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 an unknown date, the cutting pliers broke during first time use. No further information provided. This report is for one (1) plate cutter/in-line for 1. 3 mm lckng/1. 5-2. 0 mm val pl this is report 1 of 1 for (b)(4).

 
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Brand NamePLATE CUTTER/IN-LINE FOR 1.3MM LCKNG/1.5-2.0MM VAL PL
Type of DevicePLIERS,SURGICAL
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
SYNTHES TUTTLINGEN
unter hasslen 5
tuttlingen 78532
GM 78532
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8836838
MDR Text Key152504970
Report Number8030965-2019-66611
Device Sequence Number1
Product Code HTC
Combination Product (Y/N)N
Reporter Country CodeNL
PMA/PMN NumberEXEMPT
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 07/01/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/29/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number03.130.270
Device LOT NumberT155176
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/05/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/04/2018
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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