MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL KIT R1.5, TI, LEFT GAMMA3 Ø13X420MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	35253420S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/26/2024
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 long nail was implanted in pt on (b)(6) 2024.Pin in pt broken off in (b)(6).Pt ok again ((b)(6) 2024) to replace long nail.".
Event or Problem Description
As reported: "the long nail was implanted in pt on (b)(6) 2024.Pin in pt broken off in (b)(6).Pt ok again ((b)(6) 2024) to replace long nail.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged issue.The device inspection revealed the following: the received nail is completely broken in the webs of the proximal lag screw hole.There is heavy plastic deformation observed on the medial edge of the distal portion of the nail where the lag screw rests and on the medial side of the posterior web, indicative of high axial loading.This is also evident by presence of heavy lag screw bearing marks on the lateral edge of the proximal segment, superiorly.The fracture appears to have started from the lateral edge on the posterior web and progressed towards medial.The fracture pattern resembles a fatigue fracture, evident by visible lines of rest progressing from lateral to medial, relatively smooth fracture surface on initiation side (posterior web) and abrupt feature on the other side.The shiny surface on the medial edge also indicates towards a fatigue fracture (gradual separation of segments while rubbing over each other).The breakage initiated in a fatigue manner and broke instantaneously from the other side due to high tension and loading.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the provided information, it can be said that the nail broke from the proximal hole due to a fatigue fracture.The likely reason for it could be attributed to overloading, not excluding any other patient related factors.An exact root cause cannot be determined until more information like patient information and medical records are available for further evaluation.Possibility of an adverse effect of the metastases as suggested in the additional information, cannot be ruled out, but exact details must be required for a proper assessment.For this, the ifu has specified contraindication: ¿bone stock compromised by disease, infection or prior implantation that can not provide adequate support and/or fixation of the devices.Other medical or surgical conditions which would preclude the potential benefits of surgery.¿ the ifu also indicates the user that: ¿the patient should be warned that the device cannot and does not replicate a normal healthy bone, that the device can break or become damaged as a result of strenuous activity or trauma, and that the device has a finite expected service life.¿ if any additional information is provided, the investigation will be reassessed.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3 Ø13X420MM 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: 21354821
• Report Number: 0008031020-2025-00261
• Device Sequence Number: 9003075
• Product Code: HSB
• UDI-Device Identifier: 04546540409942
• UDI-Public: (01)04546540409942(17)290430(10)K1BB4E4
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 04/21/2025

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: 35253420S
• Device Lot Number: K1BB4E4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2024
• 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: Unknown