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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 11MM/125 DEG TI CANN TFNA 200MM - STERILE ROD, FIXATION, INTRAMEDULLARY

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OBERDORF SYNTHES PRODUKTIONS GMBH 11MM/125 DEG TI CANN TFNA 200MM - STERILE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.037.113S
Device Problem Break (1069)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative
Initial reporter is a synthes sales consultant. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. A review of the device history records has been requested. 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 (b)(4) reports an event as follows: it was reported that on (b)(6) 2018 a patient underwent a revision surgery due to a broken trochanteric fixation nail-advanced proximal femoral nailing system (tfna) short nail. The original implantation of tfna short nail was on (b)(6) 2018. It was unknown if there was a surgical delay. Surgical procedure and patient outcome were unknown. Concomitant devices: locking screw (part 04. 005. 528, lot l551319, quantity 1); tfna screw (part 04. 038. 200s, lot h554892, quantity 1). This report is for a tfna short nail. This is report 1 of 1 for (b)(4).
 
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Brand Name11MM/125 DEG TI CANN TFNA 200MM - 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
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key8180132
MDR Text Key130885826
Report Number8030965-2018-59172
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeBE
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 11/29/2018
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 Number04.037.113S
Device Lot NumberH539660
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/21/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/19/2018
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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