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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES MONUMENT 12MM/130 DEG TI CANN TFNA 380MM/RIGHT-STERILE ROD,FIXATION,INTRAMEDULLARY

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SYNTHES MONUMENT 12MM/130 DEG TI CANN TFNA 380MM/RIGHT-STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.037.258S
Device Problems Break (1069); Crack (1135)
Patient Problems Pain (1994); Non-union Bone Fracture (2369)
Event Type  Injury  
Manufacturer Narrative
Patient height reported as 5¿5¿. 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
Revision surgery took place on (b)(6), 2017 and was considered successful by the surgeon. The surgeon observed that both the nail and the screw were broken in two pieces. Both pieces of the nail were removed and only one piece of the screw was removed. The other part of the screw was left in the patient. The surgeon does not see a need for a follow-up surgery. Ms. Roberts said that the surgeon told her that the bone was wiggling before the surgery because of the broken devices. With the implanting of the new tfna set, the bone was stabilized. The patient is currently at rehab and no longer feels pain. The removed devices will be kept by the patient, and will not be returned.
 
Manufacturer Narrative
Device used for treatment, not diagnosis. (b)(4). Device is not expected to be returned for manufacturer review/investigation. Concomitant device reported: tfna helical blade 100 mm sterile, part #-04. 038. 300s, lot #-h258574. Quantity (1). Device history records review was conducted. The report indicates that the: manufacturing location: (b)(4), manufacturing date: 03-feb-2017, expiration date: 31-dec-2026, part #: 04. 037. 258s/lot#: h285808 (sterile) - 2 mm/130 deg ti cann tfna 380 mm/right- sterile. Qty 6. Inspection sheet for in-process/inspect dimensional/final ns063060 rev: g and inspection sheet - tfna assembly inspection met inspection acceptance criteria. Component parts reviewed: 04. 037. 942. 2 - lock prong 130 degree, tfna bp-55 lot ¿ l237859, 04. 037. 912. 4 - wave spring, shim ended bp-55 lot ¿ h045958, 04. 037. 912. 3 - tfna lock drive bp-58 lot ¿ h250095, raw material received from ati specialty materials. Certificate of test received for titanium from ati specialty materials meet specification. Raw material receiving/putaway checklist meet requirements. 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 that the patient had a tfn nail surgery for a femur fracture for the right leg on (b)(6) 2017. The femur had broken on (b)(6) 2017. The patient was implanted with a synthes titanium nail and lag screw. The surgery was completed successfully with no surgical delay and no patient harm. After experiencing pain since (b)(6) 2017, the patient had x-rays taken on (b)(6) 2017. On an office visit with a second surgeon on (b)(6) 2017, the patient was told that the x-rays revealed a crack in the titanium nail. The second surgeon said that he was hoping that the bone would fuse around the cracked device and then just heal on it¿s own. The second surgeon believed that the bone would grow around the devices that were implanted. The patient came back to see that same surgeon on (b)(6) 2017. An mri was taken which revealed that the lag screw broke into two pieces, and the titanium nail was cracked. The second surgeon then decided that a revision surgery was needed to remove the two devices and implant a new construct for the patient. The revision surgery is scheduled to take place on (b)(6) 2017. This complaint has 2 devices. Concomitant device reported: tfna helical blade 100 mm sterile, part #-04. 038. 300s, lot #-h258574. Quantity (1). This report is 1 of 2 for (b)(4).
 
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Brand Name12MM/130 DEG TI CANN TFNA 380MM/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
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6862907
MDR Text Key252093462
Report Number1719045-2017-10904
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 08/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number04.037.258S
Device Lot NumberH285808
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 Received09/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/03/2017
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: 09/13/2017 Patient Sequence Number: 1
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