MAUDE Adverse Event Report: ZIMMER GMBH ZNN CMN NAIL 11.5MMX38CM 130 R; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Catalog Number 47-2493-382-11

Device Problems Difficult to Remove (1528); Mechanical Jam (2983)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/02/2015

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices for review.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.(b)(4).

Event Description

It was reported that the patient was implanted a znn cmn nail 11.5mmx38cm 130 r on the right side on (b)(6) 2012.On (b)(6) 2015, while trying to remove the znn cmn nail, it jammed itself intramedullary and it could not be removed.Due to the risk of a femoral neck fracture the surgery was cancelled after 2,5 hours delay and the nail was left inside.

Manufacturer Narrative

It was reported that during removal of the znn after complete osteosynthesis, the nail remained stuck in the femur.The surgeon stated that the nail started to turn when is pull out of the intramedullary canal.The surgeon interrupted the surgery due to risk of femoral neck fracture.No trend identified.The compatibility check was performed and showed that the product combination was approved by zimmer.Review of incoming information: pre osteosynthetic operative x-rays: a-p and lateral view of the femur shaft.The femur shaft was completely broken into metaphyseal region with anterior-posterior dislocation.No other conspicuous information.No clear date available.Pre nail removal x-rays: a-p and lateral view of the femur shaft with the znn nail implanted.The fracture is completely healed.The znn seems to be well implanted with intact lag screw and distal screws.No other conspicuous information.No clear date available.Intraoperative picture during nail removal: focus was put in the distal femur, where the distal screws wee implanted.The sequence of intraoperative x-rays showed clearly that when the surgeon was trying to pull out the nail, the nail itself rotated on its own axis.This rotation seemed to cause soft tissue damage in the medullary canal.Implantation report dated (b)(6) 2012: a (b)(6) female patient was treated with osteosynthetic solution, after she had a right femur fracture occurred because of unknown accident.During surgery, surgeon noticed a pre-trochanter fracture; this led the surgeon to decide for a znn solution in order to fix the trochanter as well the femur fracture.Znn removal report dated (b)(6) 2015: patient asked for nail removal because she was feeling pain in the region of the lag screw and of the distal screws.Set screw, lag screw and distal screw were removed without particular effort.During nail pulling, after around 5 cm from original position, the nail started to rotate for the next 5 cm for around 90°.After these 10 cm, the nail remained stuck in the femur.The surgeon tried to avoid the nail rotation by putting a beam into lag screw hole.Despite powerful hammer hits, the surgeon was not able to extract the nail.The screw of the extraction instrument broke.It was decided to leave the nail into the bone.Possible causes for the reported event: jammed iimplant -> due to damage of screws or locking tab (distal nail); creation of burrs in long nails only (short and asia have no locking tabs); damage of implant / jammed implant (insertion and extraction) -> due to wrong design of nail / nail cap; jammed implant -> due to improper use/connection of instruments leading to incorrect screw insertion comparison to investigation results whether it is possible and justification: possible -> no screws returned, unknown if nail had burrs because surgeon was not able to remove it.Therefore it could not be excluded; not possible -> a systemic issue with design and/or material properties would have been detected within the complaint summary; possible -> it was not completely clear which instrument was used for extraction.It stated that the instrument broke during extraction but this instrument was not returned.According to surgical report, during extraction the surgeon was afraid by the fact that the nail was turning within the medullary canal.He tried to stop this rotation and further pull the nail without success, because the nail remained stuck.However, according to surgical technique, during extraction it should be considered that "the nail may rotate as it passes through the canal".However, based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective actions is not indicated and zimmer (b)(4) considers this case as closed.Zimmer's reference number of this file is (b)(4).

• Brand Name: ZNN CMN NAIL 11.5MMX38CM 130 R
• Type of Device: ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
• Manufacturer (Section D): ZIMMER GMBH; sulzerallee 8; winterthur, 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 5742676131
• MDR Report Key: 5254252
• MDR Text Key: 32292248
• Report Number: 9613350-2015-01862
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 47-2493-382-11
• Device Lot Number: 2601686
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2015
• Initial Date FDA Received: 11/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2011
• 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): Other
• Patient Age: 23 YR
• Patient Weight: 55