MAUDE Adverse Event Report: ZIMMER GMBH Z NAIL 10.5 X 75 LAG SCREW; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Catalog Number 47-2485-075-10

Device Problem Difficult to Remove (1528)

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

Event Date 11/18/2015

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive devices as they are still in vivo.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.Zimmer's reference number of this file is (b)(4).

Event Description

It was reported that the patient was implanted a z nail 10.5 x 75 lag screw on an unknown date.It was reported that during the surgery for the removal of the nail, the lag screw was fixed with bone hardly and the surgeon experienced difficulty to remove the screw.The surgery was ended without removal of the nail.

Manufacturer Narrative

The evaluation of the provided information has been made available.The device history records were reviewed and found to be conforming.The compatibility check could not be performed as only one product was reported to us.The product compatibility check is not relevant for one product only.Review of incoming information: it was reported that since the lag screw was fixed with bone hardly, the surgeon experienced difficulty of removing the screw.The devices were not returned for investigation.Neither x-rays nor surgical reports were provided.Review of surgical technique: the surgical technique doc.Nr.97-2493-004-00 rev.2 describes the correct nail and lag screw extraction."it is recommended to use the lag screw cannula as a guidance for the lag screw inserter while removing the lag screw.Assemble the lag screw inserter through the lag screw cannula into the lag screw.Use the compression device to push the lag screw cannula to the bone.Make sure that the lag screw inserter is fully seated.Hand tighten the lag screw retaining shaft with a 3.5mm hex screwdriver." possible causes for the reported event according to rmw sap doc.Nr.304809 rev.01: failure of surgery due to use of the device not compliant with defined indications.Possible, as no further information, x-rays, surgical report were provided, this point cannot be excluded.Failure of surgery wrong selection of components or use in combination with device outside the znn cmn system.Possible, as no further information, x-rays, surgical report were provided, this point cannot be excluded.Based on the given information and the results of the investigation, the complaint could not be confirmed as the alleged failure could not be identified or reproduced.Zimmer (b)(4) considers this case as closed.(b)(4).

• Brand Name: Z NAIL 10.5 X 75 LAG SCREW
• 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: 5285598
• MDR Text Key: 33239671
• Report Number: 9613350-2015-01945
• 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: 11/18/2015

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: 12/31/2017
• Device Catalogue Number: 47-2485-075-10
• Device Lot Number: 2686352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2015
• Initial Date FDA Received: 12/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2012
• 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