MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL PF, RIGHT T2 ALPHA FEMUR ANTEGRADE 10X420MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 2337-1042S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Deformity/ Disfigurement (2360); Non-union Bone Fracture (2369)

Event Date 02/08/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During a post-market clinical evaluation of the treatment of femur fractures with the femoral nail piriformis fossa (pf) of the t2 alpha femur antegrade gt/pf nailing system , the following event have been reported: "patient moved his care to another hospital system where he had a removal of hardware procedure on (b)(6) 2021 for non-union of right femur with rotational deformity.".

• Brand Name: FEMORAL NAIL PF, RIGHT T2 ALPHA FEMUR ANTEGRADE 10X420MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12606939
• MDR Text Key: 275879497
• Report Number: 0009610622-2021-00744
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613327288919
• UDI-Public: 07613327288919
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2337-1042S
• Device Catalogue Number: 23371042S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2021
• Initial Date FDA Received: 10/11/2021
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 36 YR
• Patient Weight: 104