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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TFNA FENESTRATED SCREW 95MM - STERILE ROD,FIXATION,INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH TFNA FENESTRATED SCREW 95MM - STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.038.195S
Device Problem Break (1069)
Patient Problem No Code Available (3191)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative
Unknown date in 2018. The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. A review of the device history records has been requested. (b)(4). 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 the patient underwent a revision surgery to fix a sub-trochanteric fracture on (b)(6) 2018. The patient's initial surgery was six months ago on an unknown date in 2018. In between three and six months post-op, the patient fell three times. After the third time, the patient started to feel pain in the hip. When the patient was checked in the hospital, x-ray showed that one (1) trochanteric femoral nailing system advanced (tfna) nail, and one (1) titanium (ti) tfna fenestrated screw were broken. The patient was revised with a new tfna nail and blade. The surgeon believes the breakage was due to the falls. There was no reported surgical delay. The procedure was completed successfully with the patient in stable condition. Concomitant device: distal locking screw (part# 04. 005. 530, lot# l723843, quantity# 1). This report is for one (1) tfna fenestrated screw 95mm - sterile. This is report 2 of 2 for (b)(4).
 
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Brand NameTFNA FENESTRATED SCREW 95MM - STERILE
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
SYNTHES ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8169489
MDR Text Key130504030
Report Number8030965-2018-59085
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819652323
UDI-Public(01)07611819652323
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.038.195S
Device Lot NumberH421510
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/11/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/18/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/17/2018 Patient Sequence Number: 1
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