MAUDE Adverse Event Report: STRYKER GMBH FEMORAL NAIL PF, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø10X340MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23371034S
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	01/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported the patient had a pseudarthrosis after fixation with t2alphagt nail.This was a high-energy case of motorcycle trauma.A revision surgery is scheduled for 2 may to fixate again with t2alphagt".
Event or Problem Description
As reported the patient had a pseudarthrosis after fixation with (b)(6) nail.This was a high-energy case of motorcycle trauma.A revision surgery is scheduled for (b)(6) to fixate again with (b)(6)".
Additional Manufacturer Narrative
We received a sequence of x-ray images within a pptx file which were forwarded to an hcp for review and statement ¿ his comments ¿ excerpts: « tricky one, we are only 6 weeks from implantation.I have to admit there is limited or slow healing, unfortunately there is no timepoint given for the x-rays and additional pictures¿the only comment might be that there seems to be limited compression on the fracture, which can be a factor in the healing process.» however, based on details available a more specific statement could not be made and 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.Adverse events and adverse effects are clearly pointed out in the ifu.« complications which may occur as a result of the use of intramedullary femoral nails include: delayed union, thrombosis/thrombus, non-union bone fracture, implant pain/pain, malunion of bone, pneumonia, loosening or failure of implant, nerve damage, post-operative wound infection, pressure sores, embolism/embolus, break, bone fracture(s), ossification, migration or expulsion of device, material twisted/bent, and allergic reaction.Revision and additional surgery may be a consequence of these complications.» adverse effects are clearly listed in the ifu and as pointed out ¿revision and additional surgery may be a consequence of these complications¿ with information available no deficiency of the nail in question could be verified.The labelling points out that for successful results a timely bone healing is required; this state must be achieved within a medically recognized period in such way, that the bone strength allows significantly increasing discharge of the time-fixed implant material.Furthermore, delayed union or non-union of the fracture site are clearly pointed out as adverse effects and may be rather clinical than device related.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.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.

• Brand Name: FEMORAL NAIL PF, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø10X340MM
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21475404
• Report Number: 0008031020-2025-00360
• Device Sequence Number: 3652655
• Product Code: HSB
• UDI-Device Identifier: 07613327289251
• UDI-Public: 07613327289251
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2025

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 Catalogue Number: 23371034S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Sex: Unknown