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 Problem Cut In Material (2454)

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

Event Date 11/03/2015

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices, x-rays, or other source documents for review as the patient has not been revised.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 lag screw 10.5x90 on (b)(6) 2015.On an unknown date the lag screw cut out.To date, the patient has not been revised.Since the date of the event was not reported, it will be entered as the date of this report.

Manufacturer Narrative

The device manufacturing quality records indicate that the released components met all requirements to perform as intended.The compatibility check was performed from surgical technique and showed that the product combination was approved by zimmer (b)(4).Review of incoming information: it was reported that a lag screw cut out was observed during a clinical study.An x-ray dated (b)(6), 2015 was received for the investigation.It is clearly visible that the proximal part of the lag secrew is not in the right location, rather migrated upwards.The ccd angle between the lag screw and the nail is observed to be much larger than the normal range value.Review of the surgical technique: it is stated on page 11 of the corresponding surgical technique that "to achieve sliding, tighten the set screw and then rotate the set screw inserter counterclockwise one quarter turn.Do not unscrew the set screw more than one quarter turn." possible causes for the reported event according to sap : lag screw migration -> due to incorrect lag screw design results into cut out; lag screw migration -> due to users determine wrong lag screw length; lag screw migration -> due to users apply set screw not correctly (lag screw groove not engaged).Comparison to investigation results whether it is possible and justification: not possible -> the design was validated.Furtermore, an adverse trend would have been identified; not possible -> the issue is not related to the length of the lag screw; possible -> as the set screw inserter is rotated more than the requied amount, it leads to the loosening of the lag screw.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.However, as it is stated in the surgical technique; in order to achieve sliding the set screw should be tightened and then by the help of set screw inserter it should be untightened slightly (by rotating counterclockwise one quarter turn).If it is rotated more than the given amount, it most possibly leads to cut out of the lag screw.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: 5239863
• MDR Text Key: 31737418
• Report Number: 9613350-2015-01881
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• 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

• Date FDA Received: 11/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 47-2485-090-10
• Device Lot Number: 2794458
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2015
• 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): Other
• Patient Age: 87 YR
• Patient Weight: 56