MAUDE Adverse Event Report: ZIMMER GMBH NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, LEFT, 9 HOLES, 238 MM; NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM

Model Number N/A

Device Problem Difficult To Position (1467)

Patient Problem No Information (3190)

Event Date 12/22/2016

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not receive devices, x-rays, or other source documents for review.The patient was not 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.Zimmer¿s reference number of this file is (b)(4).

Event Description

It was reported that the patient was implanted a ncb, periprosthetic femur plate, distal, left, 9 holes, 238 mm on the right side on (b)(6) 2016.It was also reported: " several holes of the plate were not threaded to accept ncb locking cap.The surgeon had to change the position of 3 screws almost implanted." the surgery was delayed for 10 minutes.Additional information has been requested and is currently not available.

Manufacturer Narrative

Investigation results were made available.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend identified.Review of event description: it was reported that several holes of the ncb pp plate were not threaded to insert the ncb locking caps.The surgeon had to change the position of 3 screws which were almost implanted.Review of received data: one picture of the surgery was provided.On the picture the plate can be seen implanted and already fixed with 6 screws on different positions.The picture does also show that tissue is located inside the bore holes where no screw is placed.No tissue should be located in the bore holes.This can happen if the surgeon drills for a ncb screw without using a ncb drill guide.Due to the tissue located in the bore holes of the ncb pp plate, it is possible that the surgeon was not able to place the ncb locking caps.However, based on the picture itself, it cannot be said if all bore holes are threaded or not, as tissue is located in the bore holes.Devices analysis: no product was returned to zimmer biomet for in-depth analysis, as it remained implanted.Review of product documentation: according to inspection plan, the required minimum scope of inspection for the screw thread (m8x0.75 6h) is: 100% visual inspection, aql 0.65 qualitative inspection, aql 1.0 quantitative inspection, aql 1.0 automated inspection.The correct implantation of the ncb pp plate is described in the surgical technique.A complaint search was performed to check if a similar complaint occurred before.The complaint search was done for the product family - ncb pp femur plates (right and left) and ncb pp distal plates (right and left).The time frame for the complaint search was from january 1st, 2016 until february 28, 2017.No complaint was found with missing thread in the bore holes.It can also be said that this is the only complaint with lot 2866921.No other complaints with lot 2866921 was registered.The lot 2866921 was released to the market on july 14, 2016.Root cause determination using rmw: - failure of surgery due to wrong selection of components or use in combination with device outside the system.- possible, it is unknown if all correct instruments were used to perform the surgery.It can be assumed from the available picture that the user did not use a ncb drill guide.- failure of surgery due to use of the device not compliant with defined indications - not possible - no evidence for device not compliant with defined indications.- failure of surgery due to missing/incomplete information available, misleading information of surgical technique or instruction of use.- not possible - no issue found with the surgical technique.- failure of surgery due to wrong/misleading information of labels.- not possible - no issue found on the labels.- failure of surgery due to insufficient warning of side effects.- not possible - no evidence for insufficient warning of side effects.Conclusion summary: it was reported that on some bore holes of the ncb pp plate the threads are missing and the surgeon had to change the position of the ncb screws as the ncb locking caps could not be placed.The plate was implanted and not returned for investigation.Only a picture was taken during the surgery which shows the plate implanted and fixed with 6 ncb screws in different positions (intra operative picture).The picture also shows that tissue is located inside the bore holes where no screw is placed.However, based on the picture itself it cannot be said if all bore holes are threaded or not as tissue is located in the bore holes.The dhr (device history records) was reviewed and did not show any abnormality.The inspection plan of this device describes that a 100% visual examination, aql 0.65 qualitative inspection, aql 1.0 quantitative inspection and aql 1.0 systematic inspection of the bore holes m8 were done before the devices were left to the market.In addition, a complaint search was done to check if a similar complaint occurred before.No complaint was found with missing thread in the bore holes.It can also be said that this is the only complaint with lot 2866921.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.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.(b)(4).

• Brand Name: NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, LEFT, 9 HOLES, 238 MM
• Type of Device: NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
• 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: 6245005
• MDR Text Key: 64584399
• Report Number: 0009613350-2017-00051
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 12/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 02.02264.109
• Device Lot Number: 2866921
• Other Device ID Number: 00889024292888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2016
• Initial Date FDA Received: 01/12/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2016
• 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