MAUDE Adverse Event Report: ZIMMER GMBH CMN FEMORAL NAIL, CCD 125°, LEFT, 11.5 MM, 21.5 CM; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/14/2016

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not receive x-rays, or other source documents for review, neither the device has been received for investigation.Where lot numbers was received for the device, the device history record were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmers reference number of this file is (b)(4).

Event Description

It is reported that a surgeon tried to implant a cmn femoral nail, ccd 125, left, 11.5 mm, 21.5 cm on (b)(6), 2016.The surgeon had difficulty to insert the lag screw and an other nail was used to finish the surgery.No harm or injury to patient and no surgery delay was reported.

Manufacturer Narrative

Investigation results were made available.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend identified.Review of event description: it was reported that during the surgery the surgeon had difficulty to insert lag screw.An alternative nail was used to finish the surgery.No health hazard was occurred to the patient.Review of received data; no medical data such as x-rays, surgical notes or any other case-relevant documents received devices analysis: visual examination: the nail, lag screw and a set screw were returned for investigation.The visual examination shows that the lag screw and the lag screw hole of the nail are highly damaged and deformed.There are material abrasion visible on the lag screw.The same damages can also be found in the lag screw hole of the nail.The thread and also the area next to the thread of the lag screw were in contact with the lag screw hole of the nail.It can be assumed that this contact was so intensive that material abrasion occurred on the lag screw surface and also in the lag screw hole of the nail.The set screw shows no damages or deformations.A measurement can not be done as the devices are highly damaged.A functional check can not be done as the devices are highly damaged.Review of product documentation: the compatibility check was performed from surgical technique and showed that the product combination was approved by zimmer biomet.The surgical technique describes the following: the diameter and length of the nail have already been determined (using nail length gauge and last size of reamer utilized).Visualizing the reduced femur and/or the contralateral femur, determine which ccd angle is appropriate for the patient.The lag screw hole labeled 125 is designed to be used with the long and asia nails containing a 125° ccd angle, the lag screw hole labeled 130 is designed to be used with the long and asia nails containing a 130° ccd angle.Root cause analysis: root cause determination using rmw: failure of surgery due to wrong selection of components or use in combination with device outside the znn cmn system, => possible, as no information was provided how the user tried to insert the lag screw into the nail.Damage of implant due to users apply impaction force on not fully connected instruments, => possible, it is possible that the instruments were not fully connected.Implant cannot be used with the mating instrument or mating implant as intended (insertion of lag screw not possible) due to users not chose the correct ccd angle targeting guide, => possible, the investigation showed that the user did not use the correct ccd angle on the targeting guide.Conclusion summary: the returned devices were investigated.The thread of the lag screw and the lag screw hole of the nail shows material abrasion.The mentioned damages must have occurred when the user tried to insert the lag screw into the lag screw hole of the nail.It can be assumed that the user did use a wrong ccd angle on the targeting guide.Therefore, the matching between these components could not be achieved.Based on the given information and the results of the investigation, we could identify a root cause for this issue.The user did not follow the surgical technique and did use a wrong ccd angle on the targeting guide.As a result the devices were damaged and the matching could not be achieved.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.(b)(4).

• Brand Name: CMN FEMORAL NAIL, CCD 125°, LEFT, 11.5 MM, 21.5 CM
• Type of Device: ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6095360
• MDR Text Key: 59748774
• Report Number: 0009613350-2016-01349
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 47-2493-211-11
• Device Lot Number: 2830898
• Other Device ID Number: 00889024298880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1