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

Catalog Number	18191015S
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/06/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Customer reported that the compression screw would not advance through the nail.
Additional Manufacturer Narrative
Investigation revealed the subject product to be a concomitant item.The device did not contribute to the reported event.
Event or Problem Description
Customer reported that the compression screw would not advance through the nail.

• Brand Name: ANKLE ARTHRODESIS NAIL, RIGHT T2 ANKLE Ø10X150MM
• Common Device Name: 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
• Report Number: 0009610622-2019-00096
• Device Sequence Number: 2326415
• Product Code: HSB
• UDI-Device Identifier: 04546540673374
• UDI-Public: 04546540673374
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K051590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 18191015S
• Device Lot Number: K02481B
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 03/07/2019
• Supplement Report FDA Received Date: 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other