MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 Ø11X380MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	34251380S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Fall (1848)
Date of Event	03/04/2025
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: "broken gamma 3 nail, implanted (b)(6) 2024, removed today.Primary surgery (b)(6) 2024 anna-kajsa harding, no problems during surgery lab tests, nothing deviant hypertoni, artrial fibrillation fell twice before she sought medical attention again.".
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: the received nail is completely broken in the webs of the proximal lag screw hole.In the microscopic view, progression lines like beach marks are clearly visible on both proximal and distal fragments which clearly indicates that it is a fatigue failure.Marks of mis-drilling also observed on the anterior web of the proximal fragment.The load bearing points could be verified at distal medial end with bulged out material indicating high compressive load axially.It looks like breakage was most likely initiated in a fatigue manner due to initial misdrilling and broke instantaneously from the other side due to high tension and loading over time.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.Some important points are mentioned in the instructions for use for post operative activities: these implants are neither intended to carry the full load of the patient acutely, nor intended to carry a significant portion of the load for extended periods of time.For this reason, post-operative instructions and warnings to patients are extremely important.External immobilization may be employed until x-rays or other procedures confirm adequate bone consolidation.The implant is intended for temporary bone fixation.In the event of a delay in bone consolidation, or if such consolidation does not take place, or if explantation is not carried out, complications may occur, for example fracture or loosening of the implant or instability of the implant system.Regular post-operative examinations (e.G.X-ray checks) are advisable.The risk of post-operative complication is higher if patients are obese and/or cannot follow the recommendations of the physician because of any mental or neuromuscular disorder.Based on investigation, it could not be excluded that the reported event is utmost likely related to the reported accident fall of the patient combined by signs of fatigue and contributed by high axial load application over the implant duration.Any medical statement regarding healing status of the bone was impossible due to missing medical records.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "broken gamma 3 nail, implanted (b)(6)2024, removed today.Primary surgery (b)(6)2022 (b)(6), no problems during surgery.Lab tests, nothing deviant.Hypertoni, arterial fibrillation.Fell twice before she sought medical attention again.".

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 Ø11X380MM X 125°
• 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: 21739997
• Report Number: 0008031020-2025-00583
• Device Sequence Number: 8626205
• Product Code: HSB
• UDI-Device Identifier: 07613252273844
• UDI-Public: (01)07613252273844(11)231113(17)281031(10)K18C73A
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2025

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: 34251380S
• Device Lot Number: K18C73A
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2023
• 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
• Patient Weight: 69 KG