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U.S. Department of Health and Human Services

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

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SYNTHES MONUMENT 10MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 456.315S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Collapse (2416)
Event Type  Injury  
Manufacturer Narrative
(b)(6) patient weight is unknown. Date of event: unknown. Additional product code: hwc. (b)(4). Implant date: unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Part 456. 315s, lot 7549740 (sterile): manufacturing location: (b)(4). Manufacturing date: december 10, 2013. Expiration date: november 30, 2022. No non-conformance reports 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. Sterility documentation was reviewed and determined to be conforming. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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.
 
Event Description
It was reported that on (b)(6) 2016 the patient was revised to a total hip because the femoral head collapsed. The patient was originally implanted with a short trochanteric fixation nail (tfn) on an unknown date. All of the original hardware was removed intact without complication. The procedure was completed successfully with no reports of delay or medical intervention. The patient's post-operative status was noted to be stable. This is report 1 of 1 for (b)(4).
 
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Brand Name10MM/130 DEG TI CANN TROCH FIXATION NAIL 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
terry callahan
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5813035
MDR Text Key50126831
Report Number1719045-2016-10563
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011857
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 07/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number456.315S
Device Lot Number7549740
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 Received07/05/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/10/2013
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: 07/21/2016 Patient Sequence Number: 1
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