MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 Ø11X360MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	34251360S
Medical Device Problem Codes	Break (1069); Fracture (1260); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2024 the patient went to emergency room where a traumatic breakage of the right femur intramedullary nail was found once the x-rays was performed (the same was not present in the x-rays performed on (b)(6) 2024).Implant date was (b)(6) 2023.Additional medical procedure was required.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since the nail was returned broken, as reported.The device inspection revealed the following: the received nail is completely broken in the webs of the proximal lag screw hole.Drill marks were found mostly along the posterior web on the proximal part of the nail.The drill marks were caused by misaligned drilling which most likely had weakened the device and had contributed to the starting point of the fracture (notching effect) somewhere at the lateral edge.The fracture pattern resembles a fatigue fracture, evident by visible lines of rest, relatively smooth fracture surface on initiation side and abrupt feature on the other side.Heavy material deformation can be seen on the edge of the hole on the distal end which most likely had created the starting point of the fracture at lateral.These strong impression marks and deformations most probably come from high compressive load, indicating the nail was exposed to continuous high load over a longer period of time.The scratches observed on several areas of the nail most probably occurred during the device explantation and are therefore not related to the implant breakage.The broken nail was returned for evaluation, and no product related issue could be detected.There was no additional information about the event provided and neither x-rays, nor operation report, nor information about patient activity was available.Therefore, the root cause of the breakage cannot be defined.The evaluation of the nail has shown that fatigue caused by high loads did lead to the breakage of the device.The visible drill marks also played a certain role as such marks have an influence on the lifetime of the nail.As a reminder, the operative technique states the following: "in the event the nail is damaged during lag screw reaming, the fatigue strength of the implant may be reduced which may cause nail to fracture." 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.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that on (b)(6) 2024 the patient went to emergency room where a traumatic breakage of the right femur intramedullary nail was found once the x-rays was performed (the same was not present in the x-rays performed on (b)(6) 2024).Implant date was (b)(6) 2023.Additional medical procedure was required.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 Ø11X360MM 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20001579
• Report Number: 0009610622-2024-00800
• Device Sequence Number: 12592468
• Product Code: HSB
• UDI-Device Identifier: 07613252273837
• UDI-Public: (01)07613252273837(17)280731(10)K16DCBE
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2024

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: 34251360S
• Device Lot Number: K16DCBE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2023
• 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: Unknown