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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø10X170MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø10X170MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 31250170S
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Dementia (1808); Fall (1848); Pain (1994); Perforation (2001); Limited Mobility Of The Implanted Joint (2671)
Event Date 01/06/2017
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Device still remains implanted.
 
Event Description
Initial surgery was performed on (b)(6) 2015. Because the patient left with inversion, lag screw was inserted above femoral head center on frontal plane. The patient visited to the hospital due to feeling of strangeness on (b)(6) 2016. The surgeon found that bone fragment was inverted and the screw came near to perforate the femoral head but the surgeon decided follow-up. When recheck 2 months after, the screw perforated to the femoral head. The patient had the pain with flexion of the hip but because patient¿s overall status is not good, revision is not planned. The patient has dementia and fell many times. Surgeon¿s opinion: 3 months after surgery, as the lag screw was slightly slide, the function of the lag screw and set screw worked well and the patient could walk in standing position a little. Why did the lag screw not slide more? if the femoral head is necrosed, does the lag screw not slide.
 
Manufacturer Narrative
Reported event refers to cutout which is usually not related to the listed device. Received x-rays showed a collapsed femur neck. The listed device did not contribute to the event - thus, concomitant item.
 
Event Description
Initial surgery was performed on (b)(6) 2015. Because the patient left with inversion, lag screw was inserted above femoral head center on frontal plane. The patient visited to the hospital due to feeling of strangeness on (b)(6) 2016. The surgeon found that bone fragment was inverted and the screw came near to perforate the femoral head but the surgeon decided follow-up. When recheck 2 months after, the screw perforated to the femoral head. The patient had the pain with flexion of the hip but because patient¿s overall status is not good, revision is not planned. The patient has dementia and fell many times. Surgeon¿s opinion: 3 months after surgery, as the lag screw was slightly slide, the function of the lag screw and set screw worked well and the patient could walk in standing position a little. Why did the lag screw not slide more? if the femoral head is necrosed, does the lag screw not slide.
 
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Brand NameTROCHANTERIC NAIL KIT, TI GAMMA3® Ø10X170MM X 125°
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6287641
MDR Text Key66124826
Report Number0009610622-2017-00043
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K034002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number31250170S
Device Lot NumberK032C52
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2017
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? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/30/2017 Patient Sequence Number: 1
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