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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TFNA FENESTRATED HELICAL BLADE 85MM - STERILE ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH TFNA FENESTRATED HELICAL BLADE 85MM - STERILE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.038.385S
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Pain (1994); No Code Available (3191)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative
Date of event is an unknown date in 2018. Additional procode: ktt. Complainant part is not expected to be returned for manufacturer review/investigation. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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. A device history record review 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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2018, patient was implanted with proximal femoral nailing system advance (tfna). Post-operatively, patient complained of pain and x-ray showed that the tfna helical blade was too long. On (b)(6) 2018, revision surgery was performed wherein the helical blade was replaced with tfna screw. There was no surgical delay reported. Patient outcome was good. At two (2) months post-operative, x-rays look normal and patient was encouraged to walk more. Six (6) days later, patient complained of pain. X-ray revealed that the tfna screw had broken. A second revision surgery was performed on (b)(6) 2018. Patient underwent total hip replacement. This report is for a tfna fenestrated helical blade. This is report 1 of 1 for (b)(4) and captures the first revision surgery. The second revision surgery is captured in (b)(4).
 
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Brand NameTFNA FENESTRATED HELICAL BLADE 85MM - 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
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7948838
MDR Text Key123194307
Report Number8030965-2018-57125
Device Sequence Number1
Product Code HSB
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 09/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.038.385S
Device Lot NumberH311751
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/23/2017
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: 10/09/2018 Patient Sequence Number: 1
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