MAUDE Adverse Event Report: STRYKER TRAUMA KIEL ANKLE ARTHRODESIS NAIL, RIGHT T2 ANKLE Ø10X150MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18191015S

Device Problem Failure to Advance (2524)

Patient Problem No Information (3190)

Event Date 02/06/2019

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device disposition is unknown.

Event Description

Customer reported that the compression screw would not advance through the nail.

Manufacturer Narrative

Investigation revealed the subject product to be a concomitant item.The device did not contribute to the reported event.

Event Description

Customer reported that the compression screw would not advance through the nail.

• Brand Name: ANKLE ARTHRODESIS NAIL, RIGHT T2 ANKLE Ø10X150MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8401842
• MDR Text Key: 139326778
• Report Number: 0009610622-2019-00096
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540673374
• UDI-Public: 04546540673374
• Combination Product (y/n): N
• PMA/PMN Number: K051590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 18191015S
• Device Lot Number: K02481B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other