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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L80 TAN ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L80 TAN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.027.051S
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Patient information is unknown. Date of event is unknown. Device malfunctioned intra-operatively and was not implanted / explanted. Reporter email address is unknown. Device is not distributed in the united states, but is similar to device marketed in the usa. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. A device history records review has been requested. (b)(4). 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 japanese pfna compression blade in question was used for femoral surgery on an unknown date. After inserting the blade, the surgeon failed in its locking by normal clockwise turns. The surgery was completed with a replacing blade in different size. There was no adverse consequence to the patient. The surgeon commented that he might have excessively turned counterclockwise when attaching the blade to an impactor. This report is for a pfna-ii blade l80 tan. This is report 1 of 1 for (b)(4).
 
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Brand NamePFNA-II BLADE L80 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 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7552929
MDR Text Key109693199
Report Number8030965-2018-54037
Device Sequence Number1
Product Code HSB
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 05/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.027.051S
Device Lot NumberL579291
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/28/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/21/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/30/2018 Patient Sequence Number: 1
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