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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES (USA) TFNA SCREW 95MM - STERILE ROD,FIXATION,INTRAMEDULLARY

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SYNTHES (USA) TFNA SCREW 95MM - STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.038.095S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Non-union Bone Fracture (2369); Impaired Healing (2378)
Event Type  Injury  
Manufacturer Narrative
Device was used for treatment, not diagnosis. Patient weight is not available for reporting. (b)(4). Implant date was provided as (b)(6) 2016. 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. 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 the patient underwent a revision procedure on (b)(6) 2016 for a refracture just below the implanted tfn-advanced proximal femoral nailing system (tfna) nail. Surgeon removed one (1) 12 mm/130 deg titanium cannulated tfna 170 mm - sterile short nail, one (1) tfna screw 95 mm - sterile, and one (1) 5. 0 mm ti locking screws w/t25 stardrive recess for im nails/sterile easily with no fragments generated. He then implanted a long tfna nail, lag screw and two distal screws. Routine intraoperative x-rays were taken. There was no surgical delay and no patient harm. The procedure was completed successfully. The patient was implanted with the hardware in (b)(6) 2016 by a different surgeon. The femoral fracture/delayed union occurred on an unknown date. This is report number 3 of 3 for (b)(4).
 
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Brand NameTFNA SCREW 95MM - 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 Key6198008
MDR Text Key63072813
Report Number2520274-2016-15743
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
Report Date 12/01/2016
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? No
Device Operator
Device Catalogue Number04.038.095S
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 Received12/01/2016
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
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