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

Model Number	2335-1238S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Impaired Healing (2378)
Date of Event	08/06/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 2nd patient with delayed union occurred 105 days after the initial surgery, is ongoing, and a low power electromagnetic osteogenic stimulator device was prescribed.The patient is a (b)(6) years old female, smoker, diabetic, and has a history of hypothyroidism, and rheumatoid arthritis.She had a standing fall, and she was admitted to the hospital with a closed left femur fracture classified as 32-b1.The device utilized for the surgical procedure was 12x380 t2 alpha femoral nail pf, and had proximal static oblique locking mode.This patient is continuing to be followed and will be included within the final study report.¿.
Additional Manufacturer Narrative
Correction: section h6 (health impact code).
Event or Problem 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.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 2nd patient with delayed union occurred 105 days after the initial surgery, is ongoing, and a low power electromagnetic osteogenic stimulator device was prescribed.The patient is a 59 years old female, smoker, diabetic, and has a history of hypothyroidism, and rheumatoid arthritis.She had a standing fall, and she was admitted to the hospital with a closed left femur fracture classified as 32-b1.The device utilized for the surgical procedure was 12x380 t2 alpha femoral nail pf, and had proximal static oblique locking mode.This patient is continuing to be followed and will be included within the final study report.¿.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.This complaint has been reported during a literature review performed by the post market surveillance group.No product identification is possible and no additional information will be requested to the customer as this serves for trending purpose.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.Based on the investigation, no definitive relation could be established between the product and the reported failure adverse consequence.As per the event description ¿delayed union¿ mentioned in the literature.Due to medical intervention, event resulting in actual severity s3.As no further information provided it can be concluded that the factors influenced delayed union might not be device related but probably linked to patient factors, poor surgical technique or failure in compliance of post-operative procedural (behavioral) requirement.If any further information is provided, the investigation report will be updated.
Event or Problem 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 (b)(4) 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 2nd patient with delayed union occurred 105 days after the initial surgery, is ongoing, and a low power electromagnetic osteogenic stimulator device was prescribed.The patient is a 59 years old female, smoker, diabetic, and has a history of hypothyroidism, and rheumatoid arthritis.She had a standing fall, and she was admitted to the hospital with a closed left femur fracture classified as 32-b1.The device utilized for the surgical procedure was 12x380 t2 alpha femoral nail pf, and had proximal static oblique locking mode.This patient is continuing to be followed and will be included within the final study report.¿ additional information received: the release of the pmcf final report showed new information related to this pi: it was reported that one patient experienced delayed union and pseudarthrosis.[.]the patient¿s last follow up was 359 days post-op, it showed interval healing but with pseudarthrosis.

• Brand Name: FEMORAL NAIL PF, LEFT T2 ALPHA FEMUR ANTEGRADE Ø12X380MM
• Common Device Name: 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: 10538483
• Report Number: 0009610622-2020-00511
• Device Sequence Number: 3749696
• Product Code: HSB
• UDI-Device Identifier: 07613327284881
• UDI-Public: 07613327284881
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/15/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: 2335-1238S
• Device Catalogue Number: 23351238S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/21/2020
• Supplement Date Received by Manufacturer: 09/30/2020; 01/18/2022
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 10/26/2020; 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female