MAUDE Adverse Event Report: ZIMMER GMBH CMN FEMORAL NAIL, CCD 125°, LEFT, 11.5 MM, 34 CM; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem Injury (2348)

Event Date 06/24/2016

Event Type  Injury  

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 were 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.(b)(4).

Event Description

It is reported that a surgeon tried to implant a "cmn femoral nail, ccd 125¿left,11.5 mm, 34 cm"on (b)(6) 2016.Surgeon hat difficulties to insert the set screw and decided to finish the surgery without the set screw.After the patient left the hospital, the lag screw subsided, (b)(4) a revision surgery was performed on (b)(6) 2016 and it was found out, that also the vein got damaged.

Manufacturer Narrative

Trend analysis: no trend identified device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Event summary: surgeon said he had difficulty inserting set screw and decided to close the wound without set screw.After leaving hospitalization, lag screw was moved inside abdominal cavity.Due to this, revision surgery was performed and it was found that patient vein got damaged.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received visual examination: the znn nail, lag screw, set screw and 2 cortical screws were returned for investigation.The visual examination of the lag screw shows that one or two grooves were damaged and also deformed.It can be assumed that this was done during the insertion of a set screw.The set screw returned do only show some damages at the hex and on the thread.No damages can be seen on the tip.In comparison with the damages on the lag screw groove it can be said that the returned set screw was not used in the surgery.The returned set screw must be another one.The znn nailing system was implanted for approx.2 months.Without a set screw.However, the lag screw does also show some circular marks on the shaft area.No abnormalities found on the nail and on the cortical screws.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: "a set screw (included in the lag screw package or packaged separately) must be used to prevent the lag screw from rotating post-operatively.Insert the tip of the fully flexible set screw inserter or 3.5mm hex screwdriver into the 3.5mm hex end of the set screw.The set screw is then passed through the connecting bolt into the proximal portion of the nail.Note: do not drive the set screw into the nail under power, as damage to the set screw or the nail could result.Note: if using the flexible captured set screw driver make sure that it is not used at an angle greater than 40°.If it is used at an angle greater than 40°, it may be damaged.The set screw should be tightened down into the groove in the lag screw.As noted above, the lag screw inserter must be positioned so that the handle on the inserter is parallel or perpendicular to the colored dots on the targeting guide in order for the set screw and lag screw grooves to engage properly.To verify engagement, attempt to twist the lag screw inserter.If it cannot be rotated using a reasonable amount of force, the construct is in the correct position.If rotation is possible, adjust the position of the lag screw (rotate slightly) so that the set screw can enter the groove in the lag screw." conclusion summary: the returned devices were investigated.The visual examination showed that the grooves of the lag screw were damaged and deformed.That must be occurred during the surgery when the user tried to insert the set screw.The set screw could not be correctly placed on the grooves.The surgical technique explains that a set screw must be used to prevent the lag screw from rotating post-operatively.Exactly this was the case in here as the user was not able to insert the set screw and the surgery was finished without inserting a set screw.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: CMN FEMORAL NAIL, CCD 125°, LEFT, 11.5 MM, 34 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: 6098401
• MDR Text Key: 59714710
• Report Number: 0009613350-2016-01352
• 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: 10/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 47-2493-341-11
• Device Lot Number: 2731550
• Other Device ID Number: 00889024299474
• 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: 02/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2013
• 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
• Patient Outcome(s): Hospitalization; Required Intervention