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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 12MM/125 DEG TI CANN TFNA 360MM/RIGHT - STERILE ROD,FIXATION,INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH 12MM/125 DEG TI CANN TFNA 360MM/RIGHT - STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.037.226S
Device Problem Break (1069)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). A review of the device history records has been requested. The investigation could not be completed; no conclusion could be drawn at the time of filing this report. 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, the patient will undergo a revision surgery due to a twice broken trochanteric fixation nail advance (tfna) nail at the aperture. Primary surgery was on (b)(6) 2018. It is unknown when the first breakage happened. The patient will be revised with a femoral recon nail (frn). Concomitant devices reported: 40mm locking screw (part# 04. 005. 530s, lot# l702526, quantity: unknown). 46mm locking screw (part# 04. 005. 536s, lot# l694087, quantity: unknown). Tfna end cap (part# 04. 038. 000s, lot# l579683, quantity: 1). Unknown plate (part# unknown, lot# unknown, quantity:1). Unknown screw (part# unknown, lot# unknown, quantity:4). This complaint involves (1) device. This report is 1 of 1 for (b)(4).
 
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Brand Name12MM/125 DEG TI CANN TFNA 360MM/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 Key8143008
MDR Text Key129648668
Report Number8030965-2018-58846
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
Type of Report Initial,Followup
Report Date 11/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.037.226S
Device Lot NumberH478712
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 Received12/12/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/19/2017
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: 12/07/2018 Patient Sequence Number: 1
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