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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES MONUMENT 11MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/RIGHT-STER ROD,FIXATION,INTRAMEDULLARY

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SYNTHES MONUMENT 11MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/RIGHT-STER ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 456.416S
Device Problem Break (1069)
Patient Problems Unspecified Infection (1930); Pain (1994); Sedation (2368)
Event Type  Injury  
Manufacturer Narrative
Part will not be returned. (b)(4). Device 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.
 
Manufacturer Narrative
Device used for treatment, not diagnosis. Patient id, age, dob and weight not provided for reporting. Additional product code: hwc. (b)(4). Device is not expected to be returned for manufacturer review/investigation. Product was not returned and no lot number was provided. Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Concomitant medical products: therapy date: (b)(6) 2016 - concomitant devices reported: 11. 0 mm titanium troch fixation nail screw/95 mm (part # 04. 032. 095s, quantity #1). (b)(4). Device history records review was conducted. The report indicates that the: manufacturing location: (b)(4), manufacturing date: 08-sep-2015, expiration date: 31-jul-2024. Part #: 456. 416s, lot#: 9892694 (sterile) - 11 mm/130 deg ti cann troch fixation nail 360 mm/right - sterile. Quantity 6. Component parts reviewed: 456. 314. 3 - trochanteric fixation nail lock driver tfn, bp 55, lot 7806315. 456. 315. 2 - trochanteric fixation nail lock 130 deg lock prong tfn, bp 58 lot 9866963. 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. ¿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.
 
Event Description
It was reported, the patient presented with a right subtrochanteric femur fracture secondary to a pathologic fracture. The patient was status post right trochanteric fixation nail (tfn) on (b)(6) 2016. He was seen in clinic reporting right hip pain, x-ray was taken on (b)(6) 2017 and it showed the implant intact. The patient reported to clinic again with continued plain and difficulty walking. On (b)(6) 2017 a repeat x-ray was taken and it showed a nonunion and a failed implant at the proximal portion of the lag screw junction. On (b)(6) 2017, dr. (b)(6) revised a right subtroch nonunion and broken tfn. The lag screw and proximal piece of the nail was removed without difficulty. The distal portion of the nail was successfully removed after multiple different attempts using different techniques. The usual techniques failed because of bony ingrowth in the cannula of the tfn. The surgeon was able to push the nail up using an osteotome through the lateral cortex window created by the lag screw. He then grabbed the proximal portion of the broken nail with pliers and pulled it out. He then revised the nail with the same sized implants and a bony strut. There was a 60-90 minute surgical delay and there was a small piece of the locking mechanism that was retained in the calcar region of the proximal femur. The procedure was successful. Patient outcome unknown. This report involves one device. Concomitant devices reported: 11. 0 mm titanium troch fixation nail screw/95 mm (part # 04. 032. 095s, quantity #1). This report is 1 of 1 for (b)(4).
 
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Brand Name11MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/RIGHT-STER
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 Key6834285
MDR Text Key165139232
Report Number1719045-2017-10863
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,Followup
Report Date 08/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number456.416S
Device Lot Number9892694
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 Received10/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/08/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/31/2017 Patient Sequence Number: 1
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