MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN ZIMMER LOCKING SCREWS; TRAUMA PROSTHESIS

Model Number N/A

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Information (3190)

Event Date 05/09/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported the patient was revised due to the locking screws backing out of the plate.

Manufacturer Narrative

No product, part number, or lot number was returned for evaluation.The condition of the device could not be observed and the device history record could not be reviewed.This device was used for treatment.Since no lot number was available no complaint history review could be conducted for the related lot number part number combination.A review of the x-ray image returned concluded: comminuted fracture humeral neck has been fixed with lateral plate and multiple screws.The proximal-most screw has backed out with at least one-half of this screw outside of the bone.The heads of three other screws are not entirely flush with the plate possibly indicative of screw back out, however; no baseline x-ray is available for review to conclusively determine if there has been migration of these three screws.No anomaly with regard to plate is noted.It is undetermined if screws may have been improperly seated at the time of surgery in the absence of baseline x-rays.The root cause of the screws backing out could not be determined.

• Brand Name: UNKNOWN ZIMMER LOCKING SCREWS
• 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: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5701530
• MDR Text Key: 46630948
• Report Number: 0001822565-2016-01919
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/11/2016

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 Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2016
• Initial Date FDA Received: 06/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention