MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL KIT R1.5, TI, LEFT GAMMA3 Ø10X300MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	35250300S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Insufficient Information (4580)
Date of Event	03/26/2025
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 end user has reported that a gamma long nail broke while the patient was walking normally, 6 months after the surgery.Now he is undergoing investigation prior to surgery to remove the nail.".
Additional Manufacturer Narrative
Correction: please refer to section d9 the device was returned.The reported event could be confirmed based on the provided x-rays and returned device.The device inspection revealed the following: the received nail is broken in the webs of the lag screw hole.The breakage surface exhibits clear signs of a fatigue fracture.Fatigue zones with a smooth surface and progression lines are visible.Material deformation can be seen on the edge of the hole on the distal end (red circle) which most likely had created the starting point of the fracture at lateral.This most probably comes from high compressive load, indicating the nail was exposed to continuous high load over a longer period of time.Altogether, the fracture pattern is characteristic of a fatigue failure.The nail likely fractured progressively due to high tension and loading over time, before ultimately failing.This event and provided x-rays were forwarded to our medical experts, with the following review: « not much info is provided, but it seems to be a delayed union / non-union.It looks like there is no support on the lateral side for the lag screw.But without the other direction and more x-rays it cannot be confirmed.If so, it would have caused movement in the interface, which would lead to fatigue failure.Based on the provided information, the root cause of the reported event is muti-factorial: the location of the fracture and the technical aspects of the surgical procedure may have contributed to the event.Furthermore, patient activity levels post-op, co-morbidities may also have contributed to an inadequate load distribution, and therefore the breakage of the implant.» 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.Based on the investigation, the root cause was attributed to a combination of user and patient condition related issue.The implant breakage occurred as a result of the bone non-union.The choice of the construct and technical aspects of the procedure may also have contributed to the non-union, and therefore failure of the implant.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "the end user has reported that a gamma long nail broke while the patient was walking normally, 6 months after the surgery.Now he is undergoing investigation prior to surgery to remove the nail.".

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3 Ø10X300MM 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: 21881829
• Report Number: 0008031020-2025-00737
• Device Sequence Number: 8742022
• Product Code: HSB
• UDI-Device Identifier: 04546540375711
• UDI-Public: (01)04546540375711(11)220124(17)261231(10)K0AB0AF
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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: 35250300S
• Device Lot Number: K0AB0AF
• 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: 03/26/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2022
• 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