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

Device Problems Corroded (1131); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Code Available (3191)

Event Date 04/01/2016

Event Type  Injury  

Manufacturer Narrative

The plate and twelve total screws were returned for review.Visual inspection revealed one screw was corroded, but the part and lot numbers of this screw are unknown.The plate and non-corroded screws do not have any significant damage or wear.Device history records for the corroded screw could not be reviewed as the part and lot numbers are unknown.These devices are used for treatment.A product history search could not be conducted on the corroded screw as the part and lot numbers are unknown.The zimmer periarticular elbow locking plate system surgical technique confirms compatibility of the plate with the eleven screws where product information is known.It was reported that the corrosion was observed as the components were being explanted, following the healed fracture.A definitive root cause cannot be determined.

Event Description

It was reported that the surgeon found corrosion or foreign material around the screw hole and on the plate while removing the implant.

• Brand Name: UNKNOWN SCREW
• 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: kathleen smith ; p.o. box 708; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6043883
• MDR Text Key: 57968724
• Report Number: 0001822565-2016-03737
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other