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

Catalog Number 47248403050

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Necrosis (1971); Loss of Range of Motion (2032); No Code Available (3191); Malunion of Bone (4529)

Event Date 09/01/2015

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.This report is number 2 of 2 mdrs filed for the same patient (reference 0001822565-2017-00430).

Event Description

It is reported that the patient underwent a trauma fixation revision approximately eight months post-implantation due to fracture of the cortical screws.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical product: zimmer natural nail 5.0mm diameter cortical screw - red fixed angle, cat #: 47248403050, lot #: 62294104.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action(s) is/are required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

It was reported patient underwent initial bilateral femoral im nail insertion performed.Subsequently, the patient underwent exchange of two locking screws on the left side approximately two weeks post implantation after the patient complained of pain at the site which the surgeon attributed to screw length.After complications from nonunion of the femoral fracture, the patient underwent additional surgeries including implantation of a cement spacer on the left side approximately one year post implantation due to delayed fracture healing and nonunion.The im nail was retained with no signs of loosening or complication.Approximately one year later, the im nail was removed due to fracture of the femoral neck screw.A left total hip prosthesis was placed.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: ZIMMER NATURAL NAIL 5.0MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE
• Type of Device: ROD, FIXATION
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• MDR Report Key: 6296837
• MDR Text Key: 66393914
• Report Number: 0001822565-2017-00432
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: PK083497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 47248403050
• Device Lot Number: 62321858
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR