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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L90 TAN ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L90 TAN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.027.053S
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Patient information is not available for reporting. Unknown when device malfunctioned. Device is not implanted/explanted. Reporter¿s address and phone number not provided for reporting. Device is not distributed in the united states, but is similar to device marketed in the usa. The subject device has been received and the product evaluation is in progress. No conclusion can be drawn. A review of the device history records has been requested and is currently pending completion. 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 europe reports an event in (b)(6) as follows: it was reported that two (2) of the proximal femoral nail-antirotation-ii (pfna ii) blades don¿t work properly, fail interlocking options. This report is for one (1) pfna-ii blade l90 tan. This is report 1 of 2 for complaint (b)(4).
 
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Brand NamePFNA-II BLADE L90 TAN
Type of DeviceROD, FIXATION, INTRAMEDULLARY
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
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7512365
MDR Text Key108194510
Report Number8030965-2018-53749
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819394223
UDI-Public(01)07611819394223
Combination Product (y/n)N
Reporter Country CodeIN
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 04/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.027.053S
Device Lot NumberL547797
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/14/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/04/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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