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	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/20/2023
Type of Reportable Event	Serious Injury
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 03-056.X-rays taken at 6-mo follow-up ((b)(6) 2023) : ap/lateral views of right femur demonstrate a well aligned and healing femoral shaft fracture.There may be some increased callus formation posteriorly but it does not appear to be united.X-rays on (b)(6) 2023 at 9-mo post-op appointment show increased callus but not bone consolidation.Plan is to manage conservatively and x-ray again at 12-month appointment.
Additional Manufacturer Narrative
The reported event of no bone consolidation 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.

• 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: 17309562
• Report Number: 0009610622-2023-00246
• Device Sequence Number: 7120663
• Product Code: HSB
• UDI-Device Identifier: 07613327288704
• UDI-Public: 07613327288704
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/12/2023

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 07/12/2023
• 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