MAUDE Adverse Event Report: STRYKER GMBH GAMMA3 - LONG NAIL KIT R1.5, TI, RIGHT D10X300MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	34250300S
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/08/2025
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: "both side nails (right and left) were prepared.A nail opened on the wrong side by the nurse, but the physician was not aware of this prior to use and only realised during the procedure.As a result of inserting the nail as is, a fracture occurred on the front outer side due to collision at the nail tip.After inserting the correct nail, two ccs pins were fixed and then wrapped the wire.".
Additional Manufacturer Narrative
A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.It has been confirmed that the event is user related and is not related to any alleged device malfunction, therefore, no device inspection is required.Based on investigation, the root cause was attributed to an user related issue, hcp did not properly check the implant before insertion, resulting in the wrong nail being implanted.Consequently, this event has been classified as off-label use.As a reminder, the instructions for use clearly state that: "every implant must be used in the correct anatomic location, consistent with accepted standards of internal fixation.Implants can be available in different versions, varying for example in length, diameter, angle, right-hand and left-hand versions, material and number of drilled holes.Select the required version carefully." a review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "both side nails (right and left) were prepared.A nail opened on the wrong side by the nurse, but the physician was not aware of this prior to use and only realised during the procedure.As a result of inserting the nail as is, a fracture occurred on the front outer side due to collision at the nail tip.After inserting the correct nail, two ccs pins were fixed and then wrapped the wire.".

• Brand Name: GAMMA3 - LONG NAIL KIT R1.5, TI, RIGHT D10X300MM X 125DEG
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23968280
• Report Number: 0008031020-2026-00001
• Device Sequence Number: 17375623
• Product Code: HSB
• UDI-Device Identifier: 04546540375322
• UDI-Public: (01)04546540375322(17)290131(10)K1A4C5C
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2026

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: Health Professional
• Device Catalogue Number: 34250300S
• Device Lot Number: K1A4C5C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/29/2024
• 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: Female