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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES MONUMENT 11MM/130 DEG TI CANN TFNA 400MM/RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY

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SYNTHES MONUMENT 11MM/130 DEG TI CANN TFNA 400MM/RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.037.160S
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Manufacturer Narrative
Device was used for treatment, not diagnosis. (b)(6). Patient weight is not available for reporting. Date of event: unknown. (b)(4). (therapy date): date of implant is unknown. The subject device is not expected to be returned to the synthes manufacturer for evaluation. A device history record review was performed for the subject device lot. The review showed that there were no issues during the manufacture or sterilization of the product that would contribute to this complaint condition. No non-conformances were generated during the production or sterilization of the subject device. 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.
 
Event Description
It was reported that revision surgery was performed on (b)(6) 2016 due to a broken unknown 130 degree trochanteric femoral nail-advanced (tfna)-right. The nail broke at the intersection of the nail and helical blade on an unknown date. The surgeon reported that the patient was non-compliant. It is also not known when the tfna system was initially implanted. During the (b)(6) 2016 revision surgery, during the removal of the helical blade, the locking mechanism of the nail broke off and fell into the patient. The surgeon was unable to retrieve the locking mechanism from the patient. The rest of the nail, helical blade and locking screw were removed and the patient and the patient was revised to a competitor's construct. There was no surgical delay and the surgery successfully completed. This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Device was used for treatment, not diagnosis. (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
This complaint addresses the need for the revision surgery due to the broken nail. See related complaint (b)(4) which addresses and reports the issue with the tfna locking mechanism. (b)(4).
 
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Brand Name11MM/130 DEG TI CANN TFNA 400MM/RIGHT - 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 Key5673753
MDR Text Key45719799
Report Number1719045-2016-10429
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK131548
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 05/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.037.160S
Device Lot Number9846221
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 Received05/09/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/07/2015
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: 05/23/2016 Patient Sequence Number: 1
Treatment
ONE UNKNOWN HELICAL BLADE
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