MAUDE Adverse Event Report: STRYKER GMBH FEMORAL NAIL, LEFT T2 GTN Ø8X300 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18500830S
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
After opening the implant, the nail was prepared.When i felt something was wrong and checked it before inserting it into the body, i found that the package and the nail itself had the word ¿left¿ engraved on them, but it was actually a right-handed implant.The operation continued with a different size implant being opened and inserted.
Event or Problem Description
After opening the implant, the nail was prepared.When i felt something was wrong and checked it before inserting it into the body, i found that the package and the nail itself had the word ¿left¿ engraved on them, but it was actually a right-handed implant.The operation continued with a different size implant being opened and inserted.
Additional Manufacturer Narrative
The reported event could be confirmed, since physical evaluation revealed a wrong shape nail.It could be verified that in comparison with the corresponding drawing 68-2122210_revaa the most prox.Hole above oblong hole seems to be incorrect for the device in question femoral nail, left t2 gtn ø8x300 mm, catalog # 18500830s / lot code k09f126.The position of the milling corresponds to that of a femoral nail, right t2 gtn ø8x300 mm according to the drawing 68-2122211 instead of femoral nail, left t2 gtn ø8x300 as per drawing 68-2122210.This was classified as a manufacturing deviation and was addressed in accordance with our procedures which will cover all further actions needed.In case substantive information becomes available in future that suggests otherwise we reserve the right to reopen the case.

• Brand Name: FEMORAL NAIL, LEFT T2 GTN Ø8X300 MM
• 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: 21510074
• Report Number: 0008031020-2025-00369
• Device Sequence Number: 7974811
• Product Code: HSB
• UDI-Device Identifier: 04546540646293
• UDI-Public: (01)04546540646293(11)210115(17)251231(10)K09F126
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Catalogue Number: 18500830S
• Device Lot Number: K09F126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/04/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2021
• 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
• Patient Age: 8 YR
• Patient Sex: Male