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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES MONUMENT 10MM/125 DEG TI CANN TFNA 300MM/LEFT - STERILE ROD,FIXATION,INTRAMEDULLARY

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SYNTHES MONUMENT 10MM/125 DEG TI CANN TFNA 300MM/LEFT - STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.037.021S
Device Problem Break (1069)
Patient Problems Failure of Implant (1924); Pain (1994); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Reportedly, revision surgery was planned on (b)(6) 2016. It is not confirmed if the revision surgery was completed. (b)(6). (b)(4). Device history records review was completed for part# 04. 037. 021s, lot# 9968157. Manufacturing location: (b)(4), manufacturing date: feb 18, 2016, expiry date: dec 31, 2025. Review of the device history records 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. The device was received and the product evaluation is in progress. No conclusion can be drawn. 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
Device report from synthes europe reports an event in (b)(6) as follow: it was reported that the reported device was used in surgery for femur subtrochanteric fracture on (b)(6) 2016. The outer cortex was almost destroyed, and the fracture included outside wall so it was hard to reduce. Two or three months after the surgery, it was hard to see porosis. Although the surgeon was worried about the bone union, he kept it under observation. Five months after the surgery, the patient went to the hospital due to pain. The surgeon confirmed that an insertion portion of a tfna (tfn-advanced proximal femoral nailing system) nail broke by x-ray photography and 3d computed tomographic scanning. A surgical revision to replace the nail with another one is planned on (b)(6) 2016. Concomitant device: locking screw stardrive® ø 5. 0mm, l 38mm (part# 04. 005. 528s, lot# 9679806, quantity: 1). Locking screw stardrive® ø 5. 0mm, l 34mm (part# 04. 005. 524, lot# 9692496, quantity: 1). This report is for one (1) cannulated tfna. This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Product investigation was completed for part# 04. 037. 021s, lot# 9968157. A visual inspection drawing review, and device history records review were performed as part of this investigation. The complaint is confirmed. The returned tfna nail was confirmed to be broken at the proximal locking hole. The returned nail, blade, and locking screws were found to have wear consistent with implant, use and removal. The helical blade shows some significant wear marks which were likely caused by interaction with the broken nail. Relevant drawings for the returned device were reviewed. During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition. The returned parts were determined to be suitable for the intended use when employed. The returned helical blade and concomitant screws in this complaint record show no evidence of having contributed to the event, and any damage to the devices appears to be as a result of the broken nail. A root cause could not be determined as the circumstances at the time of the event are unknown. 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.
 
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Brand Name10MM/125 DEG TI CANN TFNA 300MM/LEFT - 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 Key6176986
MDR Text Key62446499
Report Number1719045-2016-10917
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,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.037.021S
Device Lot Number9968157
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/05/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/18/2016
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: 12/15/2016 Patient Sequence Number: 1
Treatment
PART# 04.005.524, LOT# 9692496, QUANTITY: 1; PART# 04.005.528S, LOT# 9679806, QUANTITY: 1
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