• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SYNTHES MONUMENT 10MM/130 DEG TI CANN TFNA 170MM - STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.037.042S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Reaction (2414); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Customer quality conducted an investigation of the received x-rays. X-rays of the following parts were received. Part #: 04. 037. 042s, lot #: unk, part #: unk - screw, lot #: unk , part #: 04. 038. 100, lot #: unk. The allegation of part #: 04. 038. 100 backing out is able to be confirmed based on the x-rays provided. The tfna screw is lateral to the expected position with respect to the nail. It is unknown when the alleged backing out began to occur. The conditions experienced by the construct post-operatively are unknown. The allegation of pain and allergic reaction against all of the parts is not able to be confirmed with the x-rays. No additional device investigation is able to be completed based on the images. No root cause is able to be determined. The alleged back out issue is confirmed based on the x-rays. The allegation of pain and allergic reaction against all of the parts is not able to be confirmed with the x-rays. 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.
 
Manufacturer Narrative
Bmi calculations is (b)(6) and height is (b)(6). Date of event is unknown. Udi: (b)(4) expiration date unknown(10)lot number unknown. Contract name and telephone number is unknown. Explant date is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. The manufacture date is unknown. The investigation could not be completed; no conclusion could be drawn, as no product was received. The patient¿s allergic reaction to the staples. The staples caused a pocket to form underneath and fill up with fluid. A wound vac was used to drain the fluid out of the pocket. 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 a patient fell on an unknown date and sustained a right intertrochanteric hip fracture. Patient was admitted to the hospital on (b)(6) 2016 and was treated with a tfn-advanced proximal femoral nailing system (trochanteric fixation nail) (nail, lag screw and screw) on (b)(6) 2016. Patient did well initially but had persistent pain and drainage from her hip. During the initial procedure, staples were put in to close the incision and had to be removed immediately due to the patient¿s allergic reaction to the staples. The staples caused a pocket to form underneath and fill up with fluid. A wound vac was used to drain the fluid out of the pocket. The drainage was in place from (b)(6) 2016. Patient experienced delayed wound healing in the right hip. Patient placed in lateral position on operating room table, used a prewash prior to procedure and the patient was given antibiotics and held until cultures were taken. The subcutaneous fat fascia tissue was opened slightly, cultures were taken from the subcutaneous fat fascia and the muscles were debrided down to the level of bone using a ronguer, a curette and metzen baum scissor. The wound was irrigated with 5l of sterile saline. The deep fascia was enclosed with 0 pds figure of 8 sutures. A medium hemovac drain was placed into the subcutaneous space, the dead space was then closed as much as possible using a 3-0 monocryl suture. The skin was closed with 3 nylon using vertical mattress sutures. Incisional wound vac was placed at 75ml of suction with minimal leak. Patient taken to recovery, estimated blood loss was 25ml drains the hemovac x 1. Patient will continue to be weight bearing and the hemovac drain should continue until less than 10ml per shift. Started on vancomycin. Patient would continue until the cultures were negative or positive. Two weeks that patient had the wound vac placement ¿ done by a different physician. It was primarily serous drainage and was not sebrile. The drainage subsided. The hip was not displaced. Patient has a history of allergies to metal, but has not been tested. It was noted on an unknown date that the lag screw is working its way out of the nail towards the skin. X-rays were taken approximately one year ago. Patient is unable to lift up or move her right leg when standing and cannot lay on her side because it is painful. Patient has difficulty when walking and feels pain. The incisions healed; however, the patient is still reacting to the metal implants. Patient has autoimmune diseases which inhibits healing. Cultures taken on an unknown date were negative for infection. Patient has not been home since the surgery and has been between the hospital and nursing home since (b)(6) 2016. The surgeon is considering revision surgery by taking the lag screw out. The patient has requested information on the metal composition of the implants. This is report 1 of 3 for (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name10MM/130 DEG TI CANN TFNA 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
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6823917
MDR Text Key252103748
Report Number1719045-2017-10841
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number04.037.042S
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 Received09/28/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 08/28/2017 Patient Sequence Number: 1
-
-