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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA TFNA HELICAL BLADE 90MM STERILE ROD,FIXATION,INTRAMEDULLARY

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SYNTHES USA TFNA HELICAL BLADE 90MM STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.038.290S
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Code Available (3191)
Event Date 07/11/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Device is not expected to be returned for manufacturer review/investigation. (b)(6). (b)(4). Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. Device history records review could not be completed without lot number. Device 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 in (b)(6) as follow: it was reported that on (b)(6) 2016, patient underwent surgery for the femur trochanteric fracture. When the surgeon tried to insert the tfna (tfn-advanced proximal femoral nailing system) helical blade, the fractured section separated. Surgeon tried repositioning with some instruments, but could not complete the repositioning. The surgery was completed without alignment of the fractures line. Un-alignment of the breakage line was noted when the blade was inserted. On (b)(6) 2016, surgeon found that the blade had cut out. Surgeon confirmed the blade cut out in the x-ray taken on (b)(6) 2016. Patient underwent revision surgery on (b)(6) 2016. Surgeon explanted the blade and performed artificial bone head surgery. One of the possible causes for the incomplete repositioning could be attributed to the patient's bone quality. Revision surgery was completed successfully. No delay in surgery was reported. Complaint about back out of the blade and revision surgery is captured under com-(b)(4). Concomitant device: tfna fem nail ø12 r 130° l320 timo15 (par # 04. 037. 252s, lot # unknown, quantity: 1). This report is for one (1) tfna helical blade use error. This is report 1 of 1 for com-(b)(4).
 
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Brand NameTFNA HELICAL BLADE 90MM STERILE
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
mark vornheder
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6110051
MDR Text Key60238230
Report Number2520274-2016-15426
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.038.290S
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 Received10/21/2016
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: 11/17/2016 Patient Sequence Number: 1
Treatment
PAR # 04.037.252S, LOT # UNKNOWN, QUANTITY: 1
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