MAUDE Adverse Event Report: ZIMMER GMBH ASSEMBLY PIN

Catalog Number 02.00002.001

Device Problem Bent (1059)

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

Event Type  Other  

Event Description

It was reported that during surgery, the tip of the assembly pin of the ncb mis guide was bent which provided difficulty of continuing the procedure.It was reported that a concern was raised that this pin could break and be difficult to retrieve within the patient or table area (neither happened).

Manufacturer Narrative

The manufacturer did not receive the device for investigation but it is mentioned by complaint that it will be provided.No surgical report or x-rays were provided for review.A lot number was received for the instrument, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the info provided.As soon as additional info become available and an investigation result be available, an amended medical device report will be submitted.Zimmer's reference number of this file is (b)(4).Note: the same event happened during two surgeries with four assembly pins.All cases are reported under (b)(4).

• Brand Name: ASSEMBLY PIN
• Type of Device: ASSEMBLY PIN
• 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: 4209434
• MDR Text Key: 16540269
• Report Number: 9613350-2014-04046
• Device Sequence Number: 1
• Product Code: NQP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.00002.001
• Device Lot Number: 08.379809
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2008
• 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