MAUDE Adverse Event Report: ZIMMER GMBH NCB-DF TORQUE SCREWDRIVER 6 NM

Catalog Number 02.00024.021

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 07/21/2014

Event Type  malfunction  

Event Description

It is reported that due to unk reason the ncb-df torque screwdriver 6 nm was not in the delivered surgical kit with reference rk-0201-544-0m.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 manufacturer did not receive devices, x-rays, or other source documents for review.As no lot numbers were provided for the devices, the device history records could not be reviewed.The cause for this specific event cannot be ascertained from the info provided at this time.As soon as add'l info become available and an investigation result be available, an amended medical device report will be submitted.(b)(4).

• Brand Name: NCB-DF TORQUE SCREWDRIVER 6 NM
• Type of Device: NCB-DF TORQUE SCREWDRIVER 6 NM
• Manufacturer (Section D): ZIMMER GMBH; sulzerallee 8; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 5742676131
• MDR Report Key: 4016160
• MDR Text Key: 21494735
• Report Number: 9613350-2014-03777
• Device Sequence Number: 1
• Product Code: HRS
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.00024.021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/23/2014
• Initial Date FDA Received: 08/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other