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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TFNA HELICAL BLADE 80MM STERILE ROD,FIXATION,INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH TFNA HELICAL BLADE 80MM STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.038.280S
Device Problem Migration (4003)
Patient Problem Bone Fracture(s) (1870)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: unknown date in 2018. 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. 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 complained of continued pain after falling down at the hospital on (b)(6) 2018. The patient was then unable to walk after falling down again on (b)(6) 2018. Originally, the patient had an osteosynthesis using trochanteric femoral nail advanced (tfna) for femoral trochanteric fractures on (b)(6) 2018. On (b)(6) 2018, the surgeon assessed the patient, and it was confirmed that the helical blade had penetrated the acetabular roof. The latest x-ray images showed another fracture line other than the original fracture. Revision surgery was made on (b)(6) 2018. The procedure was completed successfully, and the tfna nail, helical blade, and screw were all removed. There was no surgical delay. Patient outcome was unknown. Concomitant devices reported: tfna femoral nail l170mm (part #: 04. 037. 012s, lot #: h540220, quantity: 1) and unknown tfna screw (part #: unknown, lot #: unknown, quantity: 1). This report is for one (1) tfna helical blade 80mm sterile. This is report 1 of 1 for (b)(4).
 
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Brand NameTFNA HELICAL BLADE 80MM 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 Key8180665
MDR Text Key130890553
Report Number8030965-2018-59175
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K131548
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,Followup
Report Date 11/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.038.280S
Device Lot NumberH599719
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 Received02/13/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/03/2018
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: 12/19/2018 Patient Sequence Number: 1
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