MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER NATURAL NAIL 5.0MM DIAMETER CORTICAL SCREW - RED - FIXED ANGLE; TRAUMA PROSTHESIS

Catalog Number 47248404050

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 08/11/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.This report is number 1 of 2 mdrs filed for the same patient (reference 1822565-2016-04582).

Event Description

It is reported that the patient was revised due to fracture of the distal screw implants approximately three weeks post-operatively.The screws were removed and replaced.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Current information is insufficient to permit a conclusion as to the cause of the event.

Event Description

It is reported that the patient was revised due to fracture of a distal screw implant approximately three weeks post-operatively.The screw was removed and replaced, and a second screw was also implanted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint sample was evaluated through a device history record review, but the event cannot be confirmed as the complaint sample was not returned for physical evaluation.The device history records were reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined.

• Brand Name: ZIMMER NATURAL NAIL 5.0MM DIAMETER CORTICAL SCREW - RED - FIXED ANGLE
• Type of Device: TRAUMA PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6155969
• MDR Text Key: 61814831
• Report Number: 0001822565-2016-04581
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK083497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 47248404050
• Device Lot Number: 62391468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 53 YR