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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L95 TAN ROD, FIXATION, INTRAMEDULLARY
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OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L95 TAN ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.027.054S
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Code Available (3191)
Event Date 05/25/2018
Event Type  malfunction  
Manufacturer Narrative
Device malfunctioned intra-operatively and was not implanted / explanted. Reporter phone number and email address are 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 during an unknown procedure on (b)(6) 2018, the surgeon was inserting the proximal femoral nail antirotation (pfna)-ii surgery blade and it would not lock. The desired compression could not be achieved. Another blade was used to complete the procedure. Surgery was completed successfully with a delay of forty (40) minutes. Patient outcome is okay. This report is for a pfna-ii blade l95 tan. This is report 1 of 1 for (b)(4).
 
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Brand NamePFNA-II BLADE L95 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 Key7629146
MDR Text Key112195750
Report Number8030965-2018-54513
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
Report Date 05/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.027.054S
Device Lot NumberL685123
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/08/2017
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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