MAUDE Adverse Event Report: ZIMMER GMBH ZNN CMN LAG SCREW 10.5X90; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Catalog Number 47-2485-090-10

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 02/27/2016

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive the device for investigation but it is mentioned by complainant that it will be provided.No surgical report or x-rays were provided for review.A lot number was received for the device, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as additional information become available and/or an investigation result be available, an amended medical device report will be submitted.(b)(4).

Event Description

It was reported that a surgery was performed with a znn cmn lag screw 10.5x90 on (b)(6) 2016.It was reported that during insertion of the lag screw, the slots in the lag screw which interlocks with the lag screw inserter broke.The screw was removed and replaced with another new lag screw.The surgery was extended for 30 minutes.

Manufacturer Narrative

It was reported that a surgery was performed with a znn cmn lag screw 10.5x90 on (b)(6) 2016.During insertion of the lag screw, the slots in the lag screw which interlocks with the lag screw inserter broke.The screw was removed and replaced with another new lag screw.The surgery was extended for 30 minutes.A technical investigation was not possible to perform, as the devices were not at hand for investigation.However, based on the available information the investigation is conducted with outcome as follows.No trend identified.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.The review of the delivered pictures confirms the breakage of the lag screw tabs.Design history records review results in the complaint investigations show no nonconformities which can be linked to this issue.The quality records indicate that all components met all requirements to perform as intended.The concerned products met all specifications and processes.The labeling is correct, claims are correct and surgical technique already covers this topic.No trigger was reached as well as out of the complaint investigation no regular off label uses could be determined, the disregard of an important step according to the surgical technique could lead to such events where a solution for a removal of a damaged lag screw is not always given.The cephalomedullary nail is designed to treat fractures of the femur, especially intertrochanteric and subtrochanteric fractures.The nail is inserted from proximal towards distal into the intramedullary canal of the femur in such a manner, that it bridges the fracture gap.A lag screw is placed through the nail from lateral towards medial into the femoral head.The lag screw is then secured with a set screw which is inserted into the nail from proximal.This kind of breakage can occur within the following known situations: within a not fully engaged and securely connected lag screw inserter/ lag screw retaining shaft.If the contact surface of the instrument and implant is too small, too high forces will be transmitted on the cams which leads to a fracture of this section; pathogenic bone diseases (e.G.Bone tumor) which affect mechanical properties of the bone (harder/ denser bone substance).The need for corrective measures 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 LAG SCREW 10.5X90
• 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: 5501596
• MDR Text Key: 40363587
• Report Number: 9613350-2016-00515
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 02/27/2016

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: 09/30/2020
• Device Catalogue Number: 47-2485-090-10
• Device Lot Number: 2828294
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2016
• Initial Date FDA Received: 03/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/05/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/15/2015
• 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): Hospitalization
• Patient Age: 87 YR
• Patient Weight: 82