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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA 11MM/130 DEG TI CANN TFNA 400MM/LEFT - STERILE ROD, FIXATION, INTRAMEDULLARY

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SYNTHES USA 11MM/130 DEG TI CANN TFNA 400MM/LEFT - STERILE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.037.161S
Device Problem Break (1069)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Device used for treatment, not diagnosis. Patient weight not provided for reporting. (b)(4). Device is not expected to be returned for manufacturer review/investigation. (b)(4). Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received. 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 a hardware removal and revision was performed on (b)(6) 2016 due to a broken tfna. The original procedure to repair a left femur fracture was performed on (b)(6) 2015. Subsequently, it was discovered that the tfna had broken at the point of interface with the helical blade. The removed hardware included the broken tfna, one intact helical blade and one intact locking screw. The patient was revised to an oncologic total hip prosthesis. The procedure was completed successfully with the patient in stable condition. This complaint involves one device concomitant devices reported: helical blade (part #04. 038. 305s, lot #unknown, quantity 1), locking screw (part #04. 005. 540, lot #unknown, quantity 1). This report is 1 of 1 for (b)(4).
 
Manufacturer Narrative
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.
 
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Brand Name11MM/130 DEG TI CANN TFNA 400MM/LEFT - STERILE
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6198795
MDR Text Key63106252
Report Number2520274-2016-15747
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/30/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.037.161S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/09/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 12/22/2016 Patient Sequence Number: 1
Treatment
HELICAL BLADE 04.038.305S,LOT UNK QTY 1; LOCKING SCREW PART #04.005.540, LOT UNK QTY 1
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