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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TFNA HELICAL BLADE 70MM STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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OBERDORF SYNTHES PRODUKTIONS GMBH TFNA HELICAL BLADE 70MM STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.038.270S
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Pain (1994); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.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.(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
It was reported that on (b)(6) 2019, the patient underwent open reduction internal fixation surgery for proximal humerus fracture and femoral subtrochanteric fracture.On an unknown date, the patient visited the hospital and reported pain on the humerus and femoral point.It was confirmed that the humerus bone head was varus, the screw head was out of the bone and the tfna blade was telescoping about 10mm.The revision surgery was completed successfully on (b)(6) 2020 to remove the screw at the humerus, the blade at femur, and insert a lag screw at femur.Concomitant device: unknown tfna nail (part#: unknown, lot#: unknown, quantity: 1).This report is for one (1) tfna helical blade 70mm sterile.This is report 1 of 2 for (b)(4).
 
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Brand Name
TFNA HELICAL BLADE 70MM STERILE
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key10755058
MDR Text Key213685564
Report Number8030965-2020-08328
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 Physician
Type of Report Initial
Report Date 10/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number04.038.270S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/02/2020
Initial Date FDA Received10/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
UNK - NAILS: TFNA
Patient Outcome(s) Required Intervention;
Patient Age61 YR
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