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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 10MM/125 DEG TI CANN TFNA 235MM/RIGHT - STERILE ROD,FIXATION,INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH 10MM/125 DEG TI CANN TFNA 235MM/RIGHT - STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.037.014S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Patient Involvement (2645)
Event Date 11/27/2018
Event Type  Injury  
Manufacturer Narrative
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. A review of the device history records has been requested. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Device was used for treatment, not diagnosis.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, during an unknown surgery, an advanced proximal femoral nailing system (tfna) was applied for femoral trochanteric fractures. After the proximal and distal areas of the tfna nail were fixed, the surgeon tried to insert a tfna end cap into the nail using a cannulated stardrive screwdriver. However, an end cap could not be inserted into the nail completely. The surgeon tried to do this by changing an insertion angle of an end cap but could not succeed. Then, the surgeon checked and confirmed it with an unknown flexible screwdriver. The surgical wound was closed. There was a surgical delay for more than 30 minutes without patient adverse consequence. This report is for (1) tfna fem nail ø10 r 125° l235 timo15. Concomitant devices reported: cannulated stardrive screwdriver (part# 03. 010. 520, lot# unknown, quantity 1); unknown flexible screwdriver (part# unknown, lot# unknown, quantity 1). This complaint involves two (2) devices. This report is 2 of 2 for (b)(4).
 
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Brand Name10MM/125 DEG TI CANN TFNA 235MM/RIGHT - STERILE
Type of DeviceROD,FIXATION,INTRAMEDULLARY
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
eimattstrasse 3
oberdorf 4436
SZ   4436
6103142063
MDR Report Key8176841
MDR Text Key130783842
Report Number8030965-2018-59152
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.037.014S
Device Lot NumberH612399
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/17/2018
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: 12/18/2018 Patient Sequence Number: 1
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