MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 31251180S

Device Problem Fracture (1260)

Patient Problems Pain (1994); Arthralgia (2355)

Event Date 02/12/2014

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device not available.

Event Description

As reported in postmarket gamma study: "(b)(6) year old male subject complained about pain during movements of the hip because of the lag screw.Fracture was consolidated and implant removed on (b)(6) 2014.

Event Description

As reported in postmarket gamma study: "an 85 year old male subject complained about pain during movements of the hip because of the lag screw.Fracture was consolidated and implant removed on (b)(6) 2014.

Manufacturer Narrative

Product inquiry states the trochanteric nail kit, ti gamma3® ø11x180mm x 125° to be the subject product.As no item was returned a physical examination was impossible and thus, evaluation will be limited to the information provided; already at filing it was stated that the device will not be available for evaluation.Review of the device history records revealed no discrepancies.We received a sequence of x-ray images which were forwarded to a hcp for a medical statement ¿ his comments [excerpts]: ¿we have the case of an 85y old woman with a pertrochanteric fracture of the right hip.According to the short further information given crif was performed on the (b)(6) of 2013 with a gamma nail.The fracture consolidated well.There are no real peculiarities when looking at the post-interventional x-rays from an ap and a lateral view.The nail and the lag screw do not show prominent positioning in the proximal femur.An irritation of the tractus iliotibialis, which often is the reason for pain in that area is very unlikely with the short portion of the lag screw showing at the lateral cortex.However, the patient complaint about ¿pain¿ in the right hip (not further specified).There is no other radiological explanation for the pain (like an advanced arthrosis of the hip joint for example).It was decided to explant the nail on the (b)(6) of 2014.No further information on the complaints is given, though.¿ furthermore, he stated that due to reported pain after the implantation and without further anamnestic detail given it could not be excluded that the pain occurred from the nail ¿¿and explantation after consolidation seems to be the right therapeutical decision in this case.¿ more detailed information about the complaint event as well as the affected device must be available in order to determine an exact root cause of the complaint event.The file will be closed formally.In case the item and / or relevant clinical information should become available, we reserve the right to update the investigation and change the root cause.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM 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
• MDR Report Key: 7382875
• MDR Text Key: 104042280
• Report Number: 0009610622-2018-00081
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 31251180S
• Device Lot Number: K240270
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 85 YR