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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES MONUMENT ROD, FIXATION, INTRAMEDULLARY

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SYNTHES MONUMENT ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Break (1069)
Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Manufacturer Narrative
It is unknown which of the two 4. 0 mm titanium (ti) locking screws were the ones that broke. Part/lot numbers for all the locking involved provided: part 04. 005. 428s (4. 0 mm ti locking screw w/t25 stardrive 38 mm f/im nails-ster), lot h060192, quantity 1, (b)(4). Part 04. 005. 420s (4. 0 mm ti locking screw w/t25 stardrive 30 mm f/im nails-ster), lot 9963952, quantity 1, (b)(4). Part 04. 005. 424s (4. 0 mm ti locking screw w/t25 stardrive 34 mm f/im nails-ster), lot 9814324, quantity 1, (b)(4). Part 04. 005. 422s (4. 0 mm ti locking screw w/t25 stardrive 32 mm f/im nails-ster), lot 7939617, quantity 1, (b)(4). Part of device remains in the patient; device not considered explanted. Complainant part is not expected to be returned for manufacturer review/investigation. Concomitant medical products: part number of concomitant plate provided as 4. 005. 346s; however, based on provided lot number, part number is most likely vp3022. 09. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 underwent revision surgery on (b)(6) 2017 due to delayed union of a distal tibia fracture. The original implant date was (b)(6) 2016 for a fracture tibia (right side). The hardware removal was due to two (2) broken unknown 4. 0 mm titanium (ti) locking screws. The hardware removal consisted of: one (1) 2. 4 mm/2. 0 mm locking compression (lc)-dynamic compression plate (dcp) fully intact, two (2) broken unknown 4. 0 mm titanium (ti) locking screws (partially removed). The surgeon removed parts of the two broken unknown 4. 0 mm titanium (ti) locking screws and the other parts of the two screws remain in the patient. One (1) 9 mm tibial nail-345 was not removed and was fully intact. The patient was revised by using the patient¿s auto graft as the bone graft, at the point of fracture and implanted with a one-third tubular plate with collar 7-holes/85 mm and six (6) unknown cortical screws. The hardware removal and implantation went fine. There was no surgical time delay and no additional medical or surgical intervention. The surgery was successfully completed. The patient status outcome is good. Concomitant devices reported: 9 mm tibial nail-345 (part unknown, lot unknown, quantity 1); and cortical screws (part unknown, lot unknown, quantity 4); 2. 4 mm/2. 0 mm locking compression (lc)-dynamic compression plate (dcp) (part 4. 005. 346s, lot 5813345). This is report 1 of 1 for (b)(4).
 
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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 Key6321987
MDR Text Key67118529
Report Number1719045-2017-10094
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103002
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 01/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received01/13/2017
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: 02/10/2017 Patient Sequence Number: 1
Treatment
FOUR UNKNOWN CORTICAL SCREWS; ONE PART 4.005.346S, LOT 5813345, PLATE; ONE UNKNOWN 9MM TIBIAL NAIL-345
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