MAUDE Adverse Event Report: ZIMMER GMBH NCB PLATE FOR FEMUR, RIGHT, 5 HOLES; NCB PLATING SYSTEM

Catalog Number 02.03260.005

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2014

Event Type  Injury  

Event Description

It is reported that due to unk reason the ncb plate for femur, right, 5 holes was not in the delivered surgical kit with reference (b)(4).It is also reported that in the current case no harm or impact to pt has occurred.Due to the fact that this kind of incident (missing surgical device in surgical kit) can cause harm to pt because in certain circumstances the surgery can not be continued /completed this case was considered as reportable.

Manufacturer Narrative

The mfr did not receive device or other source documents for review.The device mfg quality records indicate that the released components met all requirements to perform as intended.In a trend analysis no trend was identified.A cause for this specific event cannot be ascertained from the info provided at this time.As soon as additional info become available and an investigation result be available an amended medical device report will be submitted.(b)(4).

• Brand Name: NCB PLATE FOR FEMUR, RIGHT, 5 HOLES
• Type of Device: NCB PLATING SYSTEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 5742676
• MDR Report Key: 4039971
• MDR Text Key: 4904796
• Report Number: 9613350-2014-03797
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 07/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.03260.005
• Device Lot Number: 2669555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2012
• 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