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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 Problems Sticking (1597); Device Operates Differently Than Expected (2913)
Patient Problem No Code Available (3191)
Event Date 03/15/2018
Event Type  Injury  
Manufacturer Narrative
Device used for treatment, not diagnosis. Patient age, dob & weight not available for reporting. Unknown: device is not distributed in the united states, but is similar to device marketed in the usa. Device malfunctioned intra-operatively and was not implanted / explanted. Date returned to manufacturer (b)(4) used for: it was reported that blade did not insert adequately as intended while being placed thru the nail. A new blade of a different size was used to complete the procedure with a reported surgical delay of 30 minutes. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.
 
Event Description
Device report from synthes on an event in (b)(6) as follows: it was reported that the orif was applied to femoral trochanteric fracture on (b)(6) 2018. When (b)(6) pfna blade in question was inserted and passed through a nail, the blade did not go any farther. The surgeon tried to remove the blade once, but he failed to remove the blade which had been stuck to protection sleeve. The surgeon detached impactor in question from the blade and tried to put guide wire through. Because the guide wire did not go through, a new guide wire was used which failed again. Finally, a replacing blade was successfully inserted without the help of the guide wire and the protection sleeve. The surgery was completed within a 30-minute delay. There was no adverse consequence to the patient. The surgeon commented that defects, if any, inside the impactor might have occurred. Complaint involves one parts. This report is 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 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7422655
MDR Text Key105197368
Report Number8030965-2018-52995
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 03/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.027.054S
Device Lot NumberL565576
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/04/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/12/2017
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: 04/11/2018 Patient Sequence Number: 1
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