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

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.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø10X170MM X 125°
• Type of Device: ROD, 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 Key: 6287641
• MDR Text Key: 66124826
• Report Number: 0009610622-2017-00043
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K034002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• 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 Received: 01/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 31250170S
• Device Lot Number: K032C52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR