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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH BUTTRESS/COMPR-NUT F/PFNA BLADE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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OBERDORF : SYNTHES PRODUKTIONS GMBH BUTTRESS/COMPR-NUT F/PFNA BLADE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 356.817
Device Problem Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/22/2017
Event Type  malfunction  
Manufacturer Narrative
Additional narrative: device was used for treatment, not diagnosis. No patient information available for reporting. Device is an instrument and is not implanted/explanted. Complaint device is not expected to return. 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. 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)(4) reports an event in (b)(6) as follows: it was reported during a femoral trochanteric fracture repair using the pfna (proximal femoral nail antirotation) system on (b)(6) 2017, the compression nut became stuck to the aiming arm intraoperatively at the end of the procedure. It was noted the surgeon had a difficulty in detaching the compression nut from the aiming arm after use. A surgical delay of 1 minute was noted. No adverse consequence to the patient was reported. (b)(4).
 
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Brand NameBUTTRESS/COMPR-NUT F/PFNA BLADE
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
OBERDORF : SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf
SZ
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 Key7133593
MDR Text Key95734971
Report Number8030965-2017-50869
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
Report Date 11/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number356.817
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/24/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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