MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SUPRACONDYLAR NAIL T2 SCN Ø13X400MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18261340S

Device Problem Fracture (1260)

Patient Problem Fall (1848)

Event Date 01/08/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This pi is for the revision of the t2 nail.While reporting a revision of patient's left knee, rep reported that after patient had knee implanted, patient fell and sustained a femoral fracture.A t2 nail was implanted to address the fracture and was later removed at an unknown date for an unknown reason.

• Brand Name: SUPRACONDYLAR NAIL T2 SCN Ø13X400MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8304870
• MDR Text Key: 134998259
• Report Number: 0009610622-2019-00064
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540379290
• UDI-Public: 04546540379290
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 18261340S
• Device Lot Number: K0C1705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2015
• 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): Required Intervention
• Patient Age: 60 YR