MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL PF, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø12X380MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 2337-1238S

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

Patient Problems Deformity/ Disfigurement (2360); Impaired Healing (2378)

Event Date 08/06/2020

Event Type  Injury  

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.

Event Description

The manufacturer became aware of a post market clinical follow-up report received from (b)(6), in usa.The title of this report is ¿a retrospective data collection of the treatment of femoral fractures with the femoral nail piriformis fossa (pf) of the t2 alpha femur antegrade gt/pf nailing system¿ which is associated with the stryker ¿t2 alpha femur antegrade gt/pf nailing system¿.This study includes research done on 18 patients (19 cases) requiring surgery between the period march 2019 and october 2019.It was not possible to ascertain specific device details from the report, or to match the events reported with previously reported complaints.Therefore, new complaint was initiated in the system for the post-operative complication mentioned in the report.This product inquiry addresses delayed union.The report states: ¿the 3rd delayed union occurred 152 days after the initial surgery.The patient was a (b)(6) years old female, bmi 24.1, with a history of diabetes and osteoporosis.Her injury was due to standing fall and was classified as 32-a2, closed type.The device used for the surgery was 12x380 t2 alpha femoral nail pf, right with proximal static transverse locking mode, the adverse event is ongoing, and osteogenic stimulator was prescribed.¿.

Manufacturer Narrative

Correction: section h6 (health impact code).

Event Description

The manufacturer became aware of a post market clinical follow-up report received from university of louisville, in usa.The title of this report is ¿a retrospective data collection of the treatment of femoral fractures with the femoral nail piriformis fossa (pf) of the t2 alpha femur antegrade gt/pf nailing system¿ which is associated with the stryker ¿t2 alpha femur antegrade gt/pf nailing system¿.This study includes research done on 18 patients (19 cases) requiring surgery between the period (b)(6) 2019.It was not possible to ascertain specific device details from the report, or to match the events reported with previously reported complaints.Therefore, new complaint was initiated in the system for the post-operative complication mentioned in the report.This product inquiry addresses delayed union.The report states: ¿the 3rd delayed union occurred 152 days after the initial surgery.The patient was a 71 years old female, bmi 24.1, with a history of diabetes and osteoporosis.Her injury was due to standing fall and was classified as 32-a2, closed type.The device used for the surgery was 12x380 t2 alpha femoral nail pf, right with proximal static transverse locking mode, the adverse event is ongoing, and osteogenic stimulator was prescribed.¿.

Manufacturer Narrative

This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged delayed union with varus at fracture site mentioned in the article could not be confirmed, since no additional information was received from the author or the article.More detailed information about the patient medical history, the event circumstances, and medical reports must be available to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.

Event Description

The manufacturer became aware of a post market clinical follow-up report received from university of (b)(6), in usa.The title of this report is ¿a retrospective data collection of the treatment of femoral fractures with the femoral nail piriformis fossa (pf) of the t2 alpha femur antegrade gt/pf nailing system¿ which is associated with the stryker ¿t2 alpha femur antegrade gt/pf nailing system¿.This study includes research done on 18 patients (19 cases) requiring surgery between the period (b)(6)2019 and (b)(6) 2019.It was not possible to ascertain specific device details from the report, or to match the events reported with previously reported complaints.Therefore, new complaint was initiated in the system for the post-operative complication mentioned in the report.This product inquiry addresses delayed union.The report states: ¿the 3rd delayed union occurred 152 days after the initial surgery.The patient was a 71 years old female, bmi 24.1, with a history of diabetes and osteoporosis.Her injury was due to standing fall and was classified as 32-a2, closed type.The device used for the surgery was 12x380 t2 alpha femoral nail pf, right with proximal static transverse locking mode, the adverse event is ongoing, and osteogenic stimulator was prescribed.¿ additional information received: ¿patient c: delayed union: the 3rd delayed union [.], the adverse event is ongoing, and osteogenic stimulator was prescribed.The patient¿s last follow up was 427 days post op.The bone was healing with some varus at fracture site.¿.

• Brand Name: FEMORAL NAIL PF, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø12X380MM
• 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10541345
• MDR Text Key: 207164740
• Report Number: 0009610622-2020-00523
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613327289329
• UDI-Public: 07613327289329
• 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: Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2337-1238S
• Device Catalogue Number: 23371238S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2022
• 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): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female