MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN CANNULATED SCREW; JDP

Model Number N/A

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that a screw broke in the patient's foot.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

No devices or photos were received; therefore, the condition of the components is unknown.Device history records could not be reviewed as the lot number is unknown.This device is used for treatment.Compatibility could not be assessed and a product history search could not be conducted as the part and lot numbers are unknown.It is unknown whether the patient has been revised or the location of the fractured screw at this time.A definitive root cause cannot be determined with the information provided.

• Brand Name: UNKNOWN CANNULATED SCREW
• Type of Device: JDP
• 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: 5631821
• MDR Text Key: 44409826
• Report Number: 0001822565-2016-01431
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• 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: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 09/28/2016
• 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): Other