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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES MONUMENT 12MM/130 DEG TI CANN TROCH FIXATION NAIL 235MM-STERILE ROD, FIXATION, INTRAMEDULLARY

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SYNTHES MONUMENT 12MM/130 DEG TI CANN TROCH FIXATION NAIL 235MM-STERILE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 456.511S
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/30/2016
Event Type  malfunction  
Manufacturer Narrative
Device was used for treatment, not diagnosis. (b)(4). Device remains implanted in the patient. Device is unavailable for return. (b)(4). A review of the device history records has been completed. Manufacturing location: (b)(4). Manufacturing date: april, 01, 2016 expiration date: february 28, 2025 part #: 456. 511s, lot#: h060893 (sterile) - 12mm/130 deg ti cann troch fixation nail 235mm-sterile. Quantity 6. 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. Scn no: 12367, ¿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. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Device is not expected to return.
 
Event Description
It was reported that the internal screw that is pre-loaded in the trochanteric fixation nail (tfn) that locks down the lag screw was out of position and needed to be adjusted. The surgery was successfully completed with no harm to the patient. No surgical delay was reported. Concomitant device reported: lag screw (part # unknown, lot # unknown, quantity 1). This is report 1 of 1 for (b)(4).
 
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Brand Name12MM/130 DEG TI CANN TROCH FIXATION NAIL 235MM-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 Key6129884
MDR Text Key60990634
Report Number1719045-2016-10856
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 11/02/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/28/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number456.511S
Device Lot NumberH060893
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 Manufactured04/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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