• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L90 TAN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.027.053S
Device Problem Device Difficult to Maintain (3134)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Device is not distributed in the united states, but is similar to device marketed in the usa. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 proximal femoral nail antirotation (pfna-ii) blade did not work properly in which there was a failure in interlocking options. It is unknown how was the issue discovered. Patient and procedure were unknown. This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
kara ditty-bovard
eimattstrasse 3
oberdorf 4436
SZ   4436
6103142063
MDR Report Key8376057
MDR Text Key137407906
Report Number8030965-2019-61527
Device Sequence Number1
Product Code HSB
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,Followup
Report Date 02/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.027.053S
Device Lot Number2L72785
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/18/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

-
-