MAUDE Adverse Event Report: ZIMMER GMBH NCB, PH PLATE, 5 HOLES, WITH PROXIMAL LOCKED HOLES, 93 MM; NCB POLYAXIAL LOCKING PLATE SYSTEM, PROXIMAL HUMERAL PLATES

Model Number N/A

Device Problem Difficult to Insert (1316)

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

Event Date 12/06/2016

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not receive the device for investigation as it is still implanted, 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 during the implantation surgery of a ncb, ph plate, 5 holes, the screws couldn't be fixed into proximal locked 2 holes.

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 during the surgery two ncb screws could not be fixed into the ncb ph plate.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation - the correct ncb screw placement is described in the surgical technique.Conclusion summary: the affected implants were not received for investigation; therefore the condition of the components is unknown.No surgical report of implantation or intra operative x-rays were sent.The only information which is available is that the user was not able to fix the ncb screws into the ncb ph plate.The correct ncb screw placement is described in the surgical technique.In conclusion, 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 further corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer reference number of this file is (b)(4).

• Brand Name: NCB, PH PLATE, 5 HOLES, WITH PROXIMAL LOCKED HOLES, 93 MM
• Type of Device: NCB POLYAXIAL LOCKING PLATE SYSTEM, PROXIMAL HUMERAL PLATES
• 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: 6215154
• MDR Text Key: 63612452
• Report Number: 0009613350-2016-01511
• Device Sequence Number: 1
• Product Code: HRS
• 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: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• 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: 02.02262.105
• Device Lot Number: 2811527
• Other Device ID Number: 00889024292659
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2015
• 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