MAUDE Adverse Event Report: STRYKER GMBH FEMORAL NAIL PF, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø10X380MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2337-1038S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	12/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event that the patient developed deep vein thrombosis could not be confirmed, since the device(s) were not returned for evaluation and no other additional information was received from the clinical site.More detailed information about the patient's medical history, the event details and the involved device(s) must be available to determine the root cause.   if any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.H3 other text : device remains implanted in patient.
Event or Problem Description
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 subject (b)(6).Patient developed deep vein thrombosis on the ipsilateral side (right lower extremity) distal to the pf nail implant.Doppler study ((b)(6) 2023) day prior to 9 month post-op follow-up visit on (b)(6) shows dvt persists.Ortho deferred treatment to oncology due to breast cancer setting.Prescription for 5 mg eliquis still current.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.The provided details were forwarded to an hcp for review and statement ¿ [excerpts]: ¿i think that's all right.With the further diagnosis of breast cancer, it is possibly more related to this than to the nail.But since only a temporary medical intervention (eliquis) is necessary here, which can be discontinued in 6 months, the categorization is ok.¿ with given details no further technical statement could be given.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.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
Event or Problem Description
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 subject (b)(6).Patient developed deep vein thrombosis on the ipsilateral side (right lower extremity) distal to the pf nail implant.Doppler study ((b)(6) 2023) day prior to 9 month post-op follow-up visit on (b)(6) shows dvt persists.Ortho deferred treatment to oncology due to breast cancer setting.Prescription for 5 mg eliquis still current.

• Brand Name: FEMORAL NAIL PF, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø10X380MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17325045
• Report Number: 0009610622-2023-00255
• Device Sequence Number: 5537274
• Product Code: HSB
• UDI-Device Identifier: 07613327288704
• UDI-Public: 07613327288704
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2023

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: 2337-1038S
• Device Catalogue Number: 23371038S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 08/08/2023
• 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
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 111 KG