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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TFNA FENESTRATED HELICAL BLADE 90MM ¿ STERILE ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH TFNA FENESTRATED HELICAL BLADE 90MM ¿ STERILE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.038.390S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
This report is for one (1) unknown tfna helical blade/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k number is unknown. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Occupation: reporter is synthes employee. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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 reports an event in (b)(6) as follows: it was reported that on an unknown date, the trochanteric fixation nail-advanced (tfna) extractor was stuck inside the helical blade. It was unknown if there was a procedure or patient involvement. Concomitant device reported: connecting screw (part #: 338. 310, lot #: l699672, quantity: 1). This report is for one (1) unknown tfna helical blade. This is report 2 of 2 for complaint (b)(4).
 
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Brand NameTFNA FENESTRATED HELICAL BLADE 90MM ¿ STERILE
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8130971
MDR Text Key129308791
Report Number8030965-2018-58744
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K160167
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
Report Date 11/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.038.390S
Device Lot NumberH165016
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/11/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/07/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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