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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES MONUMENT 10MM/125 DEG TI CANN TFNA 170MM - STERILE ROD,FIXATION,INTRAMEDULLARY

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SYNTHES MONUMENT 10MM/125 DEG TI CANN TFNA 170MM - STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.037.012S
Device Problem Break (1069)
Patient Problems Fall (1848); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Device used for treatment, not diagnosis. (b)(4). Original implant date is unknown. Device is not expected to be returned for manufacturer review/investigation. (b)(4). A device history record (dhr) review was performed. Manufacturing location: (b)(4). Manufacturing date: 31-mar-2017. Expiration date: 28-feb-2027. Part #: 04. 037. 012s, lot#: h355168 (sterile) - 10 mm/125 deg ti cann tfna 170 mm - sterile. Quantity 6. Component parts reviewed: part 04. 037. 912. 2 - lock prong, 125 degree, tfna bp-55 lot - l338904. Part 04. 037. 912. 3 - tfna lock drive bp-58 lot ¿ h335764. Part 04. 037. 912. 4 - wave spring, shim ended bp-55 lot - h249482. Part 21127 - (b)(4) material lot bp-80 lot ¿ h201580. (b)(4) material received from supplier (b)(4) certificate of analysis received from (b)(4) for titanium meet specification. Inspection sheet for tfna assembly inspection rev: b and inspection sheet for in-process/inspect dimensional/final rev: j met inspection acceptance criteria. 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. Ethicon ((b)(4)), ¿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 a patient was originally implanted three months ago for a fractured hip. The patient recently had a fall and sustained a fracture at the junction of the lag screw and broke the nail in situ. The patient had surgery (b)(6) 2017 to remove the broken nail, intact lag screw and locking screw from the left hip. The patient was revised to a long tfn. The surgery went as planned. The patient was stable following surgery. No delay or additional intervention was necessary. This complaint is for one device. Concomitant medical devices tfna screw 80 mm sterile (part 04. 038. 090s, lot h296266, quantity 1), 5. 0 mm ti locking screw w/t25 stardrive 40 mm for im nails (part 04. 005. 530, lot number unknown, quantity 1). This report is 1 of 1 for com-(b)(4).
 
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Brand Name10MM/125 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 Key6898433
MDR Text Key87596906
Report Number1719045-2017-10988
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
Report Date 09/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.037.012S
Device Lot NumberH355168
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 Received09/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2017
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: 09/27/2017 Patient Sequence Number: 1
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