MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL GT, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø9X300MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 2333-0930S

Device Problem Material Deformation (2976)

Patient Problems Failure of Implant (1924); Implant Pain (4561)

Event Date 12/28/2021

Event Type  Injury  

Event Description

As reported: "after the surgery, the patient came to the hospital complaining of pain in the lower limbs, and an examination revealed a deformity of the nail.Revision surgery with plates is scheduled for (b)(6) 2022.".

Manufacturer Narrative

The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device is not available; device remains implanted in patient.

Manufacturer Narrative

Correction: please refer to h3 - reason code - other.The reported event was confirmed on the provided x-ray.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.The labelling clearly points out potential causes leading to implant breakage.Provided x-rays revealed the nail being bent at the level of the bone fracture.Surgeon¿s instruction regarding postoperative load application and the patient¿s behavior remained unknown.Provided patient information revealed a severe obesity resulting in the surgeon¿s opinion that obesity and atypical fracture were the factors for nail bending and should have been chipped.Without implant but with available information it could not be excluded that obesity and patient¿s behavior had contributed to the event.Above information leads to the conclusion that patient circumstances had contributed to the event.A product deficiency was not verified.In case further essential information becomes available we reserve the right to reopen the investigation and to reassess the root cause.H3 other text : the device has been explanted but the patient kept it "the patient wishes to take possession of the implant.".

Event Description

As reported: "after the surgery, the patient came to the hospital complaining of pain in the lower limbs, and an examination revealed a deformity of the nail.Revision surgery with plates is scheduled for (b)(6) 2022.".

• Brand Name: FEMORAL NAIL GT, RIGHT T2 ALPHA FEMUR ANTEGRADE Ø9X300MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• 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: 13418979
• MDR Text Key: 285676298
• Report Number: 0009610622-2022-00037
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613327286373
• UDI-Public: 07613327286373
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K191271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2333-0930S
• Device Catalogue Number: 23330930S
• Device Lot Number: K018C13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 76 KG