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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 07/17/2019
Event Type  Malfunction  
Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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 (b)(6) reports an event as follows: it was reported that the device broke during bending of a plate during a surgery. Concomitant device reported: plate (part unknown, lot unknown, quantity unknown). This report is for a plate cutter. 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 wright lane east
west chester, PA 19380
6107195000
MDR Report Key8893059
MDR Text Key154314394
Report Number8030965-2019-67225
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 07/21/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/14/2019
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 NumberT153948
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/10/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/04/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 08/14/2019 Patient Sequence Number: 1
Treatment
UNK - PLATES
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