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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES MONUMENT 10MM/130 DEG TI CANN TFNA 170MM - STERILE ROD,FIXATION,INTRAMEDULLARY

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SYNTHES MONUMENT 10MM/130 DEG TI CANN TFNA 170MM - STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.037.042S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hip Fracture (2349)
Event Date 11/02/2016
Event Type  Injury  
Manufacturer Narrative
Device was used for treatment, not diagnosis. (b)(4). Nail and construct was implanted on (b)(6) 2016, but remains successfully implanted in the patient. Device is unavailable for return. The investigation could not be completed; no conclusion could be drawn, as no product was received. A review of the device history records has been completed. Manufacturing location: (b)(4). Manufacturing date: march 30, 2016, expiration date: july 31, 2026. Part #: 04. 037. 042s, lot#: h177968 (sterile) - 10mm/130 deg ti cann tfna 170mm - sterile, quantity 6. No non-conformance records (ncrs) were generated during production. Review of the device history record(s) showed that there were no other issues during the manufacture of the product that would contribute to this complaint condition. Scn no: (b)(4) ¿sterility documentation was reviewed and determined to be conforming. " if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Device is not returning.
 
Event Description
It was reported that a patient was treated on (b)(6) 2016 for a left incomplete femoral neck intertrochanteric fracture (the fracture did not go all the way across the femoral neck) with the tfna (trochanteric femoral nail-advanced) system. As the tfn-a nail was being inserted, the femoral neck intertrochanteric fracture broke completely, and the two ends of the fracture displaced. The surgeon was able to align the fracture, and complete the reduction. The helical blade and distal locking screw were placed without complication. There was no surgical delay, no reported patient harm, and the procedure completed successfully. The surgeon took intraoperative x-rays to evaluate the fracture and the reduction. Based on the evaluation of the x-rays, no further surgical or medical intervention is indicated at this time. This report is for one (1) tfna nail this is report 1 of 1 for (b)(4).
 
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Brand Name10MM/130 DEG TI CANN TFNA 170MM - STERILE
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES MONUMENT
1051 synthes ave
monument CO 80132
Manufacturer (Section G)
SYNTHES MONUMENT
1051 synthes ave
monument CO 80132
Manufacturer Contact
mark vornheder
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6128671
MDR Text Key60929568
Report Number1719045-2016-10852
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 11/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number04.037.042S
Device Lot NumberH177968
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 Received11/02/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/30/2016
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: 11/28/2016 Patient Sequence Number: 1
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