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U.S. Department of Health and Human Services

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

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OBERDORF : SYNTHES PRODUKTIONS GMBH EXTRACTSCR F/PFNA BLADE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 03.010.411
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/03/2017
Event Type  malfunction  
Manufacturer Narrative
Complainant device is not expected to be returned for manufacturer. Review/investigation. Therapy date is (b)(6) 2017. 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.
 
Manufacturer Narrative
Device was used for treatment, not diagnosis. Patient information is not available for reporting. Device is an instrument and is not implanted/explanted. It is unknown if device is available for return. Reporter is sales representative, no facility contact available, no facility phone number available 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, that during the insertion of a proximal femoral nail antirotation (pfna) on (b)(6) 2017, the tip of extraction screw for pfna blade broke off inside the blade intraoperatively. It is unknown if the fragments were recovered. Surgical delay and patient status are unknown. Concomitant parts reported: pfna blade (part# unknown, lot# unknown, qty 1); pfna nail (part# unknown, lot# unknown, qty 1). This is report 1 of 1 for (b)(4).
 
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Brand NameEXTRACTSCR F/PFNA BLADE
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 Key7154845
MDR Text Key255820078
Report Number8030965-2017-51016
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819349483
UDI-Public(01)07611819349483(10)LOTNUMBERUNKNOWN
Combination Product (y/n)N
Reporter Country CodeNZ
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 12/04/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.010.411
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2018
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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