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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES MONUMENT 12MM TI END CAP T40 STARDRIVE 5MM EXT FOR FEMORAL NAILS-EX ROD,FIXATION,INTRAMEDULLARY

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SYNTHES MONUMENT 12MM TI END CAP T40 STARDRIVE 5MM EXT FOR FEMORAL NAILS-EX ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.003.001
Device Problem Fitting Problem (2183)
Patient Problem No Code Available (3191)
Event Date 11/17/2016
Event Type  Injury  
Manufacturer Narrative
Device used for treatment, not diagnosis. (b)(6). (b)(4): unanticipated x-rays were taken to resolve the end cap issue. Subject device has been received and is currently in the evaluation process. Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system. Device history records review was conducted. The report indicates that the: part 04. 003. 001, lot 5535144. Manufacturing location: supplier (b)(4). Manufacturing date: 09-aug-2007. Part #: 04. 003. 001, lot#: 5535144 (non-sterile) - 12mm end cap t40 stardrive 5mm ext for femoral nails-ex quantity (b)(4). No ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. 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 during stage two removal of external fixator and implantation of retrograde femoral nail procedure on (b)(6) 2016, surgeon selected 5 mm end cap and it would not engage / did not thread into the nail. Then surgeon selected 0 mm end cap however second 5 mm end cap was tested on the back table with the trial retrograde nail (ex rafn nail) and it was engaged as planned and therefore, 0 mm end cap was removed and second 5 mm end cap was inserted without any issue. There was 5 minutes delay in procedure and the surgery was completed successfully and the patient outcome was reported to be as planned. The first malfunctioned 5 mm end cap was tested on the back table with trial ex rafn nail and it would not engage the 5 mm end cap was manually removed with needle holder. Intra operative unplanned x-rays taken to resolve end cap problem and were not available for review. This complaint involves one device. Concomitant devices reported: retrograde femoral nail (part # 04. 013. 352s, lot # 7316088, quantity # 1), trial ex rafn nail (part # unknown, lot # unknown, quantity #1). This report is 1 of 1 for (b)(4).
 
Manufacturer Narrative
Device was used for treatment, not diagnosis. A product development investigation was performed for the subject device. The returned end cap has damaged threads. The threads are worn with some small nicks and deformation. The remainder of the device is in good condition. A visual inspection and drawing review were performed as part of this investigation. Use of the end cap is outlined in the titanium cannulated lateral entry femoral recon nail technique guide. The following drawings were reviewed during investigation. Extension end cap - femoral nails ¿ the design history was not found to impact the complaint condition. During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition. The returned parts were determined to be suitable for the intended use when employed. No definitive root cause was able to be determined. The issue may be related to cross threading of the end cap with the nail and/or handling of the device prior to use. Device was not implanted. 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 Name12MM TI END CAP T40 STARDRIVE 5MM EXT FOR FEMORAL NAILS-EX
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
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6167349
MDR Text Key62183786
Report Number1719045-2016-10905
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040336
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 11/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.003.001
Device Lot Number5535144
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/28/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/05/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/09/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/12/2016 Patient Sequence Number: 1
Treatment
04.013.352S, RETROGRADE FEMORAL NAIL; TRIAL EX RAFN NAIL, PART, LOT # UNK, UNK, QTY
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