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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH IMPACTOR F/PFNA BLADE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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OBERDORF SYNTHES PRODUKTIONS GMBH IMPACTOR F/PFNA BLADE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 03.010.410
Device Problem Sticking (1597)
Patient Problem No Code Available (3191)
Event Date 02/17/2018
Event Type  Injury  
Manufacturer Narrative
Device was used for treatment, not diagnosis. No patient information available for reporting. Device is not considered implanted or explanted. Device has not been returned for investigation. Reporter telephone number reported as (b)(6). Device is not distributed in the united states, but is similar to device marketed in the usa. Patient code is for prolonged sedation and change medical treatment plan. 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 proximal femoral nailing (pfna ii) procedure to treat a trochanteric fracture on (b)(6) 2018, the impactor became stuck in the blade intraoperatively. The surgeon had successfully attached the pfna blade by counter-clock wise movement with its impactor and inserted the device. At the time of detaching the impactor, he found that it was not rotating clockwise, resulting in the impactor not being detached from the blade. As a result the surgeon removed the entire construct and used a dynamic hip screw (dhs) (which was there as a back-up support) to complete the surgery. A ninety (90) minute surgical delay was noted. This is report 2 of 2 for (b)(4).
 
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Brand NameIMPACTOR F/PFNA BLADE
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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 Key7353428
MDR Text Key102948302
Report Number8030965-2018-52245
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,Followup
Report Date 02/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.010.410
Device Lot Number8562547
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 Received05/14/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/20/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/20/2018 Patient Sequence Number: 1
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