MAUDE Adverse Event Report: ZIMMER GMBH ZNN, CMN LAG SCREW, 10.5 MM, 105 MM INCLUDING SET SCREW; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number N/A

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 11/04/2016

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive the device for investigation.No surgical report was provided for review.X-rays were received and will be reviewed within the investigation process.Where lot number were received for the devices, the devices 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.Zimmer's reference number of this file is (b)(4).

Event Description

It was reported that the patient had a znn, cmn lag screw, 10.5 mm, 105 mm implanted on (b)(6) 2016.On (b)(6) 2016, the patient reportedly fell and heard a pop.X-rays showed that the nail had fractured at the lag screw junction.All components were removed and revised on (b)(6) 2016.Note: this is a split case with zimmer inc, (b)(4).

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: it was reported that the patient had a fall and heard a pop.The x-rays showed a broken nail.Review of received data: three x-rays were received dated (b)(6) 2016.On the x-rays it can be seen that the nail is broken through the hole for the lag screw.In addition it is visible that the femur bone is re-fractured.Devices analysis: the broken nail, lag screw and the set screw were returned for investigation.The visual examination sows that the nail was broken through the lag screw hole.The surface of the lag screw hole shows also some deformations at the contact points with the lag screw where the forces are transmitted.The fracture surface characterized by beach lines depict the fatigue character of the fracture.On both fracture surfaces no material defects that could have triggered the fracture could be detected.The lag screw shows some polished areas and damages in the middle part around the grooves.The set screw has a damaged tip, which is compatible with the contact of a lag screw groove.Review of product documentation: the compatibility check was performed and showed that the product combination was approved by zimmer biomet.Conclusion summary: it was reported that the patient had a fall and heard a pop.The taken x-rays shows a breakage of the nail.The visual examination of the returned products indicates that no material defects that could have triggered the fracture could be detected.Based on the given information and the results of the investigation, we could identify a root cause for this issue.The nail was broken due to patient fall.The need for further corrective measures is not indicated and zimmer (b)(4) considers this case as closed.(b)(4).

• Brand Name: ZNN, CMN LAG SCREW, 10.5 MM, 105 MM INCLUDING SET SCREW
• 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: 6180712
• MDR Text Key: 62596666
• Report Number: 0009613350-2016-01448
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 47-2485-105-10
• Device Lot Number: 2794466
• Other Device ID Number: 00889024298460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2015
• 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
• Patient Age: 53 YR