MAUDE Adverse Event Report: STRYKER GMBH T2 ALPHA FEMUR RETROGRADE - FEMORAL NAIL RETROGRADE D10X240MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23391024S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Ambulation or Postural Difficulties (2544)
Date of Event	02/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "on (b)(6) 2024, t2alpha-retro nail was used for a supracondylar fracture after tka, but the nail completely broke postoperatively, can't walk.Date of event happened is unknown.The broken nail is scheduled to be replaced by the another company's retrograde nail on (b)(6) 2025 after the removal.
Event or Problem Description
As reported: "on october 1, 2024, t2alpha-retro nail was used for a supracondylar fracture after tka, but the nail completely broke postoperatively, can't walk.Date of event happened is unknown.The broken nail is scheduled to be replaced by the another company's retrograde nail on (b)(6) 2025 after the removal.
Additional Manufacturer Narrative
Correction - please refer to d1 product long description, d4 (catalog & lot number), d4 gtin, h6 method code.The reported event could be confirmed, since physical device inspection revealed the nail to be broken.As per event description, the broken nail is scheduled to be replaced by the another company's retrograde nail on (b)(6) 2025 after the removal, which could be seen as a hint that the fracture was not healed at all.Provided screenshot sequence of x-ray images was forwarded to an hcp for review and comments his excerpts: ¿looks like a non-union, not a lot of callus formation at all.There also is 0 compression on the fracture line from the start, this might have contributed to the non-union.The extra hole in the nail is exactly at the height of the fracture, continuous movement of the fracture and due to that in the nail probably caused fatigue breakage in the nail at the height of the hole.¿ based on the above it could not be excluded that the case is linked to insufficient healing contributed by missing compression.The labelling clearly points out as following.The t2 alpha femoral nail retrograde is designed for temporary implantation until bone consolidation occurs.If bone consolidation does not occur or if the consolidation is insufficient, the implant may break.A review of the device history for the reported lot did not indicate any abnormalities.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.

• Brand Name: T2 ALPHA FEMUR RETROGRADE - FEMORAL NAIL RETROGRADE D10X240MM
• 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: 21475403
• Report Number: 0008031020-2025-00362
• Device Sequence Number: 17056982
• Product Code: HSB
• UDI-Device Identifier: 07613327292633
• UDI-Public: (01)07613327292633(17)331231(10)K19822A
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 23391024S
• Device Lot Number: K19822A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2024
• 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